quality director

Eaton

<div><div><div><div><h2 class="jobSectionHeader">What you&rsquo;ll do:
</h2></div><div>Eaton Corporation&rsquo;s Global Energy Infrastructure Solutions (GEIS) division is seeking a Director of Quality for the North America Region, supporting the Crouse-Hinds and B-Line business units. This position will be based at the Syracuse, NY or Highland, NY locations and relocation within hiring country is offered.
 
Reporting to the Director of Operations and functionally to the Global Director of Quality, the incumbent will be responsible for leading and aligning quality strategies, systems, and processes across the North America Region to ensure compliance, drive continuous improvement, and support operational excellence. This is a highly visible position which will lead the processes to prepare for key customer quality communications and business review activities as well as cost-out activities and quality improvements.
The incumbent must maintain customer confidence, through customer issue problem resolution, building strong professional relationships with external customer leadership as well as internal Eaton operational, sales, engineering, and project management leadership.
<div>Job Responsibilities:
 
<ul><li>Provide leadership oversight of quality problem solving activities for 11 manufacturing plants&rsquo; select strategic customers and suppliers
</li><li>Collaborate with plant cross-functional teams to identify root cause analyses in order to generate corrective action plans and assist in verifying the effectiveness of those actions. The incumbent will leverage tools within the Eaton Quality Systems to address quality concerns (e.g. 8D, root cause analysis, PFMEA, control plans, etc.) and communicate with customers as appropriate.
</li><li>Engage and leverage available quality data to provide trend analysis and insight to opportunities for improvement through the life cycle of products driving significant year over year performance improvement for both new business opportunity and existing install base
</li><li>Conduct customer satisfaction workshops (Business Process Improvements events and / or Emergent Learning Events) to improve group customer quality, and individual competency to exceed customer expectations
</li><li>Partner with Key Account Sales and Marketing Managers and Engineering Services to remedy critical customer complaint issues, acting as coordinator representing ES Americas Quality for specific customers
</li><li>Provide functional coaching, mentoring, evaluation and development of site Quality Managers
</li><li>Focus on bringing the Voice of Customer into the plants and help to develop individual plant strategies for quality. This will include training and supporting competency development and risk mitigation strategies.
</li><li>Utilize reduction of risk and improvement of quality base to help drive out cost from the business inclusive of lack of productivity, reduction of COPQ, supplier resourcing and other opportunities.
</li></ul></div></div></div><div><div><h2 class="jobSectionHeader">Qualifications:
</h2></div><div><div>Preferred Qualifications:
 
<ul><li>Bachelor&rsquo;s degree from an accredited institution
</li><li>Minimum ten (10) years of experience with progressive levels of accountability and responsibility in Manufacturing/Operations, Quality, Continuous Improvement, and/or Manufacturing Engineering is required
</li><li>Minimum five (5) years of plant manufacturing leadership experience is required
</li><li>Eaton will not consider applicants for employment immigration sponsorship or support for this position. This means that Eaton will not support any CPT, OPT, or STEM OPT plans, F-1 to H-1B, H-1B cap registration, O-1, E-3, TN status, I-485 job portability, etc. 
</li></ul></div><div> 
Preferred Qualifications:
 
<ul><li>Bachelor&rsquo;s degree in Engineering
</li><li>Six Sigma Greenbelt certification
</li><li>Working knowledge of Quality Management System standards and AIAG requirements
</li><li>ASQ Certified Quality Engineer
</li><li>Customer support experience
</li></ul></div></div></div><div><div><h2 class="jobSectionHeader">Skills:
</h2></div><div><div>Position Criteria:
 
<ul><li>Strong customer focus and drive to be customer advocate
</li><li>Strong business acumen
</li><li>Strong problem solving skills and methodology, such as six sigma, 8D, 5WHY
</li><li>Strong product, process, and or quality engineering background
</li><li>Effective oral and written communication skills as well as planning and organizational skills
</li><li>Ability to convey professional formal presentations appropriate for Executive Level audience
</li><li>Ability to travel up to 30 percent
</li><li>Ability to multi-task and work effectively at multiple organizational levels.
</li></ul></div></div></div><div><div><h2 class="jobSectionHeader">Additional Information:
</h2></div><div>It is important that the Regional Quality Director has a thorough understanding of the high level interactions among regional / divisional portfolio of product and organization to efficiently and effectively navigate a large matrixed organization to quickly resolve customer quality concerns.. Individual must be able to work through aggressive customer demands and work directly with divisional / plant resources to directly address customer quality concerns, ensuring adequate use of resources where it is deemed most necessary and cost effective. Ensure relationships with external select customers are managed in a manner that exceeds their expectations in terms of communication, responsiveness and results.
</div></div></div>At Eaton, we strive to provide compensation and benefits that attract, engage, and retain the best talent. This includes competitive pay and a variety of benefit programs for eligible employees. The expected annual salary range for this role is $165000 - $242000 a year. This role is also eligible for a variable incentive program. Please note the salary information shown above is a general guideline only. Salaries are based upon candidate skills, experience, and qualifications, as well as market and business considerations. 
We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law. 
Eaton believes in second chance employment. Qualified applicants with arrest or conviction history will be considered regardless of their arrest or conviction history, consistent with the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act and other local laws. 
You do not need to disclose your conviction history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Eaton is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. 
To request a disability-related reasonable accommodation to assist you in your job search, application, or interview process, please call us at 1-800-836-6345 to discuss your specific need. Only accommodation requests will be accepted by this phone number. 
We know that good benefit programs are important to employees and their families. Eaton provides various Health and Welfare benefits as well as Retirement benefits, and several programs that provide for paid and unpaid time away from work. Click here for more detail: Eaton Benefits Overview. Please note that specific programs and options available to an employee may depend on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements.</div>

Quality Director

Anderson Rehabilitation Institute

<div>Your experience matters<div>
 Anderson Rehabilitation Institute Center is part of Lifepoint Health, a diversified healthcare delivery network with facilities coast to coast. We are driven by a profound commitment to prioritize your well-being so you can provide exceptional care to others. As a Quality Director joining our team, you&rsquo;re embracing a vital mission dedicated to making communities healthier &reg;. Join us on this meaningful journey where your skills, compassion and dedication will make a remarkable difference in the lives of those we serve.</div><div></div><div> 
Why join us</div>
Fundamental to providing great care is supporting and rewarding our team. In addition to your base compensation, this position also offers:
<ul><li>Health (Medical, Dental, Vision) and 401K Benefits for full-time employees</li><li>
Competitive Paid Time Off</li><li>
Employee Assistance Program &ndash; mental, physical, and financial wellness assistance</li><li>
Tuition Reimbursement/Assistance for qualified applicants</li><li>
And much more...</li></ul><div></div><div> 
How you&rsquo;ll contribute</div><div>
Lead and oversee a comprehensive, efficient, and integrated hospital-wide Continuous Quality and Performance Improvement (CQPI) program. Use data collection, analysis, and trending to assess performance; focus on process and systems improvement; direct risk management and patient safety activities; investigate adverse outcomes, coordinate regulatory/accreditation readiness, and educate staff on CQPI and related quality programs.</div><div></div><div> 
ESSENTIAL FUNCTIONS:</div><ul><li>
Provide leadership and oversight of the organization-wide CQPI program.</li><li>
Measure and assess performance by collecting, analyzing, and trending data to identify opportunities for improvement.</li><li>
Focus on improving processes and systems to drive clinical quality, safety, and operational performance.</li><li>
Direct, facilitate, and report on all aspects of risk management and patient safety.</li><li>
Investigate factors contributing to adverse outcomes and drive process/system changes.</li><li>
Direct the hospital-wide CQPI operations, including record reviews for quality indicators and reporting findings to leadership, Medical Executive Committee, Board of Managers, and other committees.</li><li>
Annually review hospital-wide plans for Infection Control (IC) and CQPI; establish goals and objectives for the coming year.</li><li>
Serve as liaison to local health officials, coordinate inspections and accreditation reviews with state and other regulatory agencies.</li><li>
Perform other duties as assigned.</li></ul><div></div> 
ADDITIONAL INFORMATION:<ul><li>
Develop and deliver hospital-wide CQPI education and training.</li><li>
Prepare quality/patient safety reports and dashboards for leaders and committees.</li><li>
Partner with clinical and non-clinical departments to sustain improvements and ensure compliance with applicable standards.</li><li>
This position also leads the departments of Case Management, outcomes and HIM. Knowledge or experience in case management is preferred. We will be in our survey window soon so looking for someone that is goal directed, organized and can take initiative for being proactive in identifying issues and implementing solutions.</li></ul> 
Qualifications &amp; Requirements:<ul><li>
Experience: Minimum two (2) years in an acute hospital or rehabilitation setting required; prior supervisory experience preferred.</li><li>
Licensure: Registered Nurse with current state licensure highly preferred; clinical license required</li><li>
Education: BSN or BS/BA required.</li><li>
Certifications: Basic Life Support (BLS/CPR) required; certification preferred by APIC (American Practitioners of Infection Control) and NAHCQ (National Association of Health Care Quality).</li></ul> 
Skills:<ul><li>
Data analysis and reporting; CQPI methodologies (e.g., RCA, FMEA, PDSA)</li><li>
Risk management and patient safety facilitation</li><li>
Regulatory/accreditation readiness</li><li>
Effective teaching, communication, and collaboration.</li></ul><div> 
Schedule: Day</div><div></div><div> 
EEOC Statement</div>
Anderson Rehabilitation Institute is an Equal Opportunity Employer. Anderson Rehabilitation Institute is committed to Equal Employment Opportunity for all applicants and employees and complies with all applicable laws prohibiting discrimination and harassment in employment.
We employ and provide care to people from all walks of life. We are committed to promoting healing, providing hope, preserving dignity and producing value with an inclusive workforce in which diversity is leveraged, respected, and reflective of the patients, family members, customers and team members we serve.Lifepoint Health is a leader in community-based care and driven by a mission of Making Communities Healthier. Our diversified healthcare delivery network spans 29 states and includes 63 community hospital campuses, 32 rehabilitation and behavioral health hospitals, and more than 170 additional sites of care across the healthcare continuum, such as acute rehabilitation units, outpatient centers and post-acute care facilities. We believe that success is achieved through talented people. We want to create places where employees want to work, with opportunities to pursue meaningful and satisfying careers that truly make a difference in communities across the country.</div>

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
People Leader
All Job Posting Locations:
Cairo, Egypt
Job Description:
J&amp;J Innovative Medicine is recruiting for a Commercial Quality Director reporting to the EMEA Commercial Quality Head and to be based in New Cairo, Egypt.
Key Responsibilities<ul><li>
The overall purpose of this job is to ensure the daily availability of high-quality products and services in the Emerging Markets in EMEA (Russia, CIS countries, the Middle-East and Africa). This role is also the quality point of contact for health equity activities.</li><li>
This position reports directly to the Commercial Regional Quality Head EMEA and reports in dotted line to the Managing Director, Emerging Markets.</li><li>
In collaboration with the members of the Emerging Markets (EM) leadership team and the Quality Heads of individual markets, this individual is responsible for developing Quality objectives, enabling the commercial strategy to serve patients.</li><li>
This position ensures that a Quality Management system (QMS) is established and implemented to ensure compliance across all countries in the Emerging Markets, collaborating with other technical functions including Regulatory Affairs, Medical Safety, Medical Affairs, and Regional Demand &amp; Supply</li><li>
This role serves a critical function in translating complex Quality topics for clear understanding with business leaders across the organization</li><li>
This individual will work with regional leaders to identify and implement optimization improvements for Quality processes, working with agility in the Emerging Markets</li><li>
This role leads a team, including hiring, coaching and development across a diverse group of countries</li></ul>
Qualifications<ul><li>
Bachelor's degree in life science or engineering, Master's degree is preferred</li></ul><ul><li>
Minimum 5 years of experience in a highly regulated industry, including pharmaceuticals or medical devices</li><li>
Minimum 3 years of people leadership experience, preferably in an Emerging Markets context</li><li>
Excellent communication and influencing skills</li><li>
Applying digital tools and capabilities to optimize business processes</li></ul><ul><li>
Experience working in a GxP environment, interacting with Health Authorities</li><li>
Strong project management skills, working in an ambiguous environment</li></ul><ul><li>
Fluency in English is required</li><li>
Additional languages related to the Emerging Markets team (Arabic, Russian, etc) are an advantage</li></ul>
Required Skills:
Quality Management Systems (QMS)
Preferred Skills:
Continuous Improvement, ISO 9001, Quality Standards, Stakeholder Engagement</div>

Commercial Quality Director

Scientific Search

<div>
 
 Director of Quality
 
 
 
 Location: Sanford, FL
 
 
 Ready to take the next step into leadership? This is a unique opportunity to step into a Director-level role where you&rsquo;ll shape and elevate the Quality function at a growing, agile organization. You&rsquo;ll have the autonomy to influence systems, drive compliance strategy, and make a lasting impact on product quality and patient outcomes.
 
 
 
 Why You Should Apply
 
 
 
 <ul>
 <li>
 Competitive salary range
 </li>
 <li>
 Ideal &ldquo;step-up&rdquo; Director role with high visibility and ownership
 </li>
 <li>
 Opportunity to build, refine, and lead quality systems in a growing company
 </li>
 <li>
 Direct influence on compliance strategy and regulatory readiness
 </li>
 <li>
 Collaborative leadership environment with executive exposure
 
 
 </li>
 </ul>
 
 What You&rsquo;ll Be Doing
 
 
 
 <ul>
 <li>
 Lead and oversee core Quality Systems including deviations, CAPA, change control, and audits
 </li>
 <li>
 Guide quality strategy to ensure compliance with cGMP and regulatory standards
 </li>
 <li>
 Review and approve critical QA documentation including batch records and SOPs
 </li>
 <li>
 Drive continuous improvement initiatives across QA/QC functions
 </li>
 <li>
 Partner cross-functionally with operations, manufacturing, and leadership teams
 </li>
 <li>
 Prepare for and support regulatory inspections and internal audits
 
 
 </li>
 </ul>
 
 About You
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related)
 </li>
 <li>
 Strong expertise in cGMP and pharmaceutical quality systems
 </li>
 <li>
 Experience leading or owning quality programs and compliance initiatives
 </li>
 <li>
 Proficiency with eQMS and quality documentation systems
 </li>
 <li>
 Strategic thinker with strong communication and leadership presence
 
 
 </li>
 </ul>
 
 How To Apply
 
 
 
 We&rsquo;d love to see your resume, but we don&rsquo;t need it to have a conversation. Send us an email to emily@scientificsearch.com and tell me why you&rsquo;re interested. Or, feel free to email your resume. Please include Job#19808.
 
 
</div>

Quality Assurance Director

Renesas Electronics

<div>
 
 Job Description
 
 
 
 
 Renesas Electronics America, Inc. is looking for a Senior Customer Quality Engineering Director to lead strategic quality team supporting key customers. This role serves as the primary quality interface between our organization and global key accounts, ensuring flawless execution, rapid issue resolution, and continuous quality improvement across advanced semiconductor technologies.
 
 
 
 
 The Senior Customer Quality Manager will manage and develop a team of Customer Quality Engineers (CQEs) while operating at both technical and executive levels, driving customer confidence, protecting revenue, and strengthening long-term relationships.
 
 
 
 
 
 Responsibilities:
 
 
 
 
 
 
 
 Customer Quality Leadership
 
 
 
 <ul>
 <li>
 Act as the senior quality focal point for top-tier global customers, managing all quality-related engagements and escalations
 </li>
 <li>
 Own customer quality performance metrics (PPM, RMA, SCARs, audits, and scorecards) and ensure commitments are consistently met or exceeded
 </li>
 <li>
 Lead executive-level customer reviews, quality summits, and strategic business reviews
 </li>
 </ul>
 
 
 
 
 
 Team Leadership &amp; Development
 
 
 
 <ul>
 <li>
 Manage, mentor, and develop a team of Worldwide Customer Quality Engineers, setting clear objectives and performance expectations
 </li>
 <li>
 Allocate resources and prioritize workload across customers, products, and escalations
 </li>
 <li>
 Establish best practices for customer engagement, issue resolution, and communication consistency across the CQE team
 </li>
 <li>
 Serve as a senior escalation point for complex or high-impact customer quality issues
 </li>
 </ul>
 
 
 
 
 
 Issue Resolution &amp; Risk Management
 
 
 
 <ul>
 <li>
 Drive end-to-end resolution of complex customer quality issues, from containment through root cause and permanent corrective action
 </li>
 <li>
 Lead cross-functional teams (fab, assembly/test, R&amp;D, product engineering, supply chain, etc.) using structured problem-solving methodologies
 </li>
 </ul>
 
 
 
 
 
 Strategic Improvement &amp; Influence
 
 
 
 <ul>
 <li>
 Partner with internal leadership to influence design-for-quality, process robustness, and reliability strategies
 </li>
 <li>
 Use customer feedback and field data to drive continuous improvement and reduce cost of poor quality
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Education: BSEE or MSEE
 </li>
 <li>
 Experience: 8+ years of experience in Customer Quality or Product Engineer supporting customers and/or the business unit.
 </li>
 <li>
 Experience managing quality for Top Tier Customers
 </li>
 <li>
 Expertise in structured problem-solving and root cause analysis
 </li>
 <li>
 Strong knowledge of semiconductor manufacturing processes (wafer fab, assembly, test, and reliability)
 </li>
 <li>
 Excellent communication skills with the ability to influence at technical, operational, and executive levels
 </li>
 <li>
 Experience leading geographically distributed teams
 </li>
 <li>
 Available to support domestic &amp; international business travel
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 
 The expected annual pay range for this position is $165-$210K. This position is also eligible for bonus opportunities. Please note that final offer amount will be dependent on geographic location, applicable experience, and skillset of the candidate.
 
 
 
 
 Renesas offers a full range of elective benefits including medical, health savings account (with applicable medical plan), dental, vision, health and/or dependent care flexible spending accounts, pre-tax commuter benefits, life insurance, AD&amp;D, and pet insurance. In addition to elective benefit options, benefited employees receive company-paid life insurance and AD&amp;D, LTD, short term medical benefits as well as paid sick time, paid holidays, and accrued paid vacation. New employees will attend a detailed benefit orientation to learn more about our many benefits and resources.
 
 
 
 
 Renesas is an embedded semiconductor solution provider driven by its Purpose &lsquo;
 
 To Make Our Lives Easier
 
 .&rsquo; As the industry&rsquo;s leading expert in embedded processing with unmatched quality and system-level know-how, we have evolved to provide scalable and comprehensive semiconductor solutions for automotive, industrial, infrastructure, and IoT industries based on the broadest product portfolio, including High Performance Computing, Embedded Processing, Analog &amp; Connectivity, and Power.
 
 
 
 
 With a diverse team of over 22,000 professionals in more than 30 countries, we continue to expand our boundaries to offer enhanced user experiences through digitalization and usher into a new era of innovation. We design and develop sustainable, power-efficient solutions today that help people and communities thrive tomorrow, &lsquo;
 
 To Make Our Lives Easier
 
 .&rsquo;
 
 
 
 
 At Renesas, you can:
 
 
 
 <ul>
 <li>
 
 Launch and advance your career
 
 in technical and business roles across four Product Groups and various corporate functions. You will have the opportunities to explore our hardware and software capabilities and try new things.
 </li>
 </ul>
 <ul>
 <li>
 
 Make a real impact
 
 by developing innovative products and solutions to meet our global customers' evolving needs and help make people&rsquo;s lives easier, safe and secure.
 </li>
 </ul>
 <ul>
 <li>
 
 Maximize your performance and wellbeing
 
 in our flexible and inclusive work environment. Our people-first culture and global support system, including the remote work option and Employee Resource Groups, will help you excel from the first day.
 </li>
 </ul>
 
 Are you ready to own your success and make your mark?
 
 
 
 
 Join Renesas.
 
 Shape Your Future with Us
 
 .
 
 
 
 
 Renesas Electronics is an equal opportunity and affirmative action employer, committed to celebrating diversity and fostering a work environment free of discrimination on the basis of sex, race, religion, national origin, gender, gender identity, gender expression, age, sexual orientation, military status, veteran status, or any other basis protected by federal, state or local law. For more information, please read our Diversity &amp; Inclusion Statement.
 
 
 
 
 Renesas Electronics deals with dual-use technology that is subject to U.S. export controls regulations. Under these regulations it may be necessary for Renesas to obtain U.S. government export license prior to release of technology to certain persons. The decision whether or not to file or pursue an export license application is at the sole discretion of Renesas.
 
 
 
 
 We have adopted a hybrid model that gives employees the ability to work remotely two days a week while ensuring that we come together as a team in the office the rest of the time. The designated in-office days are Tuesday through Thursday for innovation, collaboration and continuous learning.
 
 
 
</div>

Quality Engineering Director

Bristol Myers Squibb

<div>Working with Us 
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 
 
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . 
 
Position Summary: 
This position will develop comprehensive internal and vendor quality oversight strategies for In Vitro Diagnostics (IVD), Companion Diagnostics (CDx), and Digital health assets within a regulated environment. The Director will serve as a key collaborator across external partners, internal R&amp;D, Regulatory, Clinical, IT/Digital, and Quality organizations, ensuring fit-for-purpose, risk-based quality oversight aligned with a rapidly evolving global diagnostic and digital health regulatory landscape. 
 
This role is accountable for the development, implementation, and continuous improvement of QMS processes and oversight, including global audit strategy, vendor quality oversight, inspection readiness, and regulatory intelligence for IVD, CDx and Digital health programs. This position will report to the Sr. Director of Laboratory Quality Assurance. 
 
Key Responsibilities:
<ul><li>Serve as the primary Quality strategic partner to external diagnostic, CDx, SaMD, and digital health vendors, influencing quality expectations early in development lifecycles.</li><li>
Lead fit-for-purpose Quality frameworks for external partnerships, balancing innovation speed with regulatory compliance</li><li>
Drive partner engagement models that move beyond transactional audits toward continuous, risk-based oversight.</li><li>
Act as a change leader to modernize Quality practices traditionally designed for drugs/biologics to support diagnostics, software, and data-driven products.</li><li>
Own BMS global quality and audit strategies for diagnostic and Digital Health vendors, including CROS, Labs, software developers, and data providers</li><li>
Serve as a trusted inspection-facing leader, engaging directly with Health Authorities as needed.</li><li>
Utilizes Quality Risk Management (QRM) tools and innovative analytics/digital capabilities to achieve the optimal Quality Strategy in accordance with company objectives to proactively identify risk areas, streamline processes, and drive effectiveness and efficiency.</li><li>
Oversee vendor qualification audits and Third-Party Risk Management activities.</li><li>
Partner with business teams to address quality issues, including investigations, impact assessments, resolutions, and documentation.</li><li>
Lead/assist in the development and implementation of new Standard Operating Procedures (SOPs) as required.</li><li>
Coordinate inspection readiness activities and provide inspection support (e.g., inspection strategy room presence).</li><li>
Serve as the primary contact for PEARL assessments for IVD devices and SaMD (within GCP regulated area).</li><li>
Support GCP Deviation Root Cause investigations in partnership with Business stakeholders.</li><li>
Conduct business analysis to identify and implement continuous process improvements.</li><li>
Effective verbal and written communication and interpersonal relationship skills.</li><li>
Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management.</li><li>
Good presentation skills, deliver focused message to audience of peers, stakeholders and Regulatory Agency Inspectors</li><li>
Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment.</li></ul>
Qualifications:
<ul><li>Bachelor's degree in Life Sciences, Engineering, or related field; advanced degree preferred.</li><li>
Experience in quality management, vendor oversight, and audit strategy in the IVD, CDx, or SaMD sector.</li><li>
Demonstrate deep expertise in diagnostic and digital health-specific audit execution, including design controls, software validation, data integrity, and lifecycle management.</li><li>
Comprehensive knowledge of GCP, ISO, GLP, GMP relevant regulatory requirements, and risk management frameworks.</li><li>
Demonstrated experience leading investigations and root cause analysis.</li><li>
Strong written and verbal communication skills; ability to partner across functions.</li><li>
Analytical mindset with a focus on process improvement and compliance.</li></ul>
Additional Skills:<ul><li>
Knowledge of PEARL assessments and strategy room operations during regulatory inspections.</li><li>
Experience developing and maintaining SOPs.</li><li>
Capacity for business partnering and change management in a dynamic environment.</li></ul>
#LI-Hybrid 
 
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
 
 
Compensation Overview: 
 
Princeton - NJ - US: $188,250 - $228,114
 
 
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
 
 
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
 
 
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
<ul><li>Health Coverage: Medical, pharmacy, dental, and vision care.</li><li>
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
</li><li>Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
</li></ul>Work-life benefits include:
 
 
Paid Time Off
<ul><li>US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
</li><li>Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
</li></ul>Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
 
 
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. 
 
<ul><li>Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
</li></ul> 
Uniquely Interesting Work, Life-changing Careers 
With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 
 
On-site Protocol 
 
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
 
 
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
 
 
Supporting People with Disabilities 
 
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
 
 
Candidate Rights 
 
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R1601006 : Director - Diagnostic &amp; Digital Health Quality Strategy</div>

Director - Diagnostic & Digital Health Quality Strategy

Axcelis Technologies

<div>
 
 Job Description
 
 
 
 
 Position Summary
 
 
 
 The Director of Manufacturing Quality at Axcelis Technologies will lead global strategic and operational initiatives to ensure world?class manufacturing quality across all Axcelis production sites. This role is responsible for driving First Time Right manufacturing, defect prevention, process capability, and factory readiness, ensuring that semiconductor capital equipment is built consistently, reliably, and in full compliance with quality and regulatory requirements. This leader will partner closely with Manufacturing Operations, Manufacturing Engineering, Product Engineering, Supplier Quality, and Customer Quality to embed quality at the source, reduce manufacturing escapes, and continuously improve factory performance. The ideal candidate is a strategic, hands?on quality leader with deep experience in complex, high technology manufacturing environments and a proven ability to scale quality systems in support of business growth.
 
 
 
 Key Responsibilities
 
 
 
 Manufacturing Quality Leadership &amp; Strategy
 
 
 <ul>
 <li>
 Define and execute the global Manufacturing Quality strategy aligned with organization?s business objectives and growth plans.
 </li>
 <li>
 Serve as the primary quality partner to Manufacturing Operations leadership.
 </li>
 <li>
 Ensure consistent manufacturing quality standards, processes, and execution across all factories.
 
 
 </li>
 </ul>
 Factory Quality &amp; Process Control
 
 
 <ul>
 <li>
 Own manufacturing quality performance including defect rates, rework, scrap, escapes, DOAs, in-box quality, and out?of?box quality.
 </li>
 <li>
 Establish and maintain standardized workmanship requirements, inspection plans, quality gates, and control plans.
 </li>
 <li>
 Ensure manufacturing processes are capable, repeatable, auditable, and scalable.
 
 
 </li>
 </ul>
 Defect Prevention &amp; Issue Resolution
 
 
 <ul>
 <li>
 Lead root cause analysis (RCA), corrective and preventive actions (CAPA), and structured problem?solving using 8D, A3, and other methodologies.
 </li>
 <li>
 Drive rapid containment and permanent corrective actions for manufacturing nonconformances.
 </li>
 <li>
 Partner with Engineering to prevent recurrence through design, process, and documentation improvements.
 
 
 </li>
 </ul>
 Quality Systems &amp; Compliance
 
 
 <ul>
 <li>
 Oversee the development and continuous improvement of ISO 9001?compliant manufacturing quality systems within the Axcelis Management System (AMS).
 </li>
 <li>
 Ensure compliance with internal procedures, regulatory requirements, and customer expectations.
 </li>
 <li>
 Lead internal audits, factory readiness reviews, and manufacturing process assessments.
 
 
 </li>
 </ul>
 Cross?Functional Collaboration
 
 
 <ul>
 <li>
 Collaborate with Manufacturing Engineering, Product Engineering, Test, and Supply Chain to embed quality early in the product lifecycle.
 </li>
 <li>
 Partner with Supplier Quality to ensure effective incoming quality, containment, and supplier corrective actions.
 </li>
 <li>
 Work closely with Customer Quality to reduce manufacturing escapes and improve customer perception of factory quality.
 
 
 </li>
 </ul>
 Performance Management &amp; Continuous Improvement
 
 
 <ul>
 <li>
 Establish, monitor, and report manufacturing quality KPIs and metrics.
 </li>
 <li>
 Champion Lean, 5s, Six Sigma, SPC, and continuous improvement initiatives across manufacturing.
 </li>
 <li>
 Drive accountability through data?driven decision making and regular governance.
 
 
 </li>
 </ul>
 Team Development &amp; Leadership
 
 
 <ul>
 <li>
 Build, mentor, and lead a high?performing global Manufacturing Quality team.
 </li>
 <li>
 Foster a culture of ownership, prevention, and continuous improvement.
 </li>
 <li>
 Develop talent and support succession planning to meet future business needs.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 Required:
 
 
 <ul>
 <li>
 Bachelor?s degree in Engineering or a related technical field; Master?s degree preferred.
 </li>
 <li>
 10+ years of progressive experience in manufacturing quality or operations quality within semiconductor capital equipment or high?tech manufacturing.
 </li>
 <li>
 Proven experience leading manufacturing quality teams in complex environments.
 </li>
 <li>
 Strong knowledge of ISO 9001, manufacturing quality systems, and process control methodologies.
 </li>
 <li>
 Expert in quality tools and methodologies (FMEA, SPC, 8D, RCA, CAPA, Lean, Six Sigma).
 </li>
 <li>
 Proven ability to lead cross?functional teams and influence at all organizational levels.
 </li>
 <li>
 Strong communication &amp; presentation skills with both technical &amp; executive audiences.
 </li>
 <li>
 Ability to travel domestically and internationally as required (30%).
 
 
 </li>
 </ul>
 
 Preferred
 
 
 
 <ul>
 <li>
 Experience supporting high?mix, low?to?medium volume capital equipment manufacturing.
 </li>
 <li>
 Experience working in global manufacturing environments.
 </li>
 <li>
 Six Sigma Black Belt, ASQ CQE, or ISO Lead Auditor certification.
 </li>
 <li>
 Strong passion for quality, operational excellence, and continuous improvement.
 
 
 </li>
 </ul>
 
 EQUAL OPPORTUNITY STATEMENT
 
 
 
 It is the policy of Axcelis to provide equal opportunity in all areas of employment for all persons free from discrimination based on race, sex, religion, age, color, national origin, disability status, medical condition (including pregnancy), veteran status, sexual orientation, marital status, or any other characteristic protected by federal, state or local law. Axcelis will provide reasonable accommodation necessary to enable a disabled candidate or employee to perform the essential functions of the position, unless the accommodation would create an undue hardship for the Company.
 
 
 
 U.S. BASE SALARY RANGE
 
 
 
 $168,283.60 - $252,425.40
 
 
 This base salary range reflects the typical compensation for this role across U.S. locations.
 
 
 Our salary ranges are determined by role and level; individual pay is determined based on
 
 
 multiple factors, including job-related skills, experience, relevant education or training, work
 
 
 location, and internal equity. The range provides the opportunity for growth and progression as
 
 
 you develop within the role.
 
 
 Base pay is one part of our U.S. total compensation package which includes eligibility in the
 
 
 Axcelis Team Incentive bonus plan, and comprehensive benefits package (for regular
 
 
 employees working 20+ hours a week).
</div>

Director of Manufacturing Quality

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Director - Diagnostic & Digital Health Quality Strategy

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