director of quality

Mensor LP

***Please apply directly on the Mensor website at www.mensor.com***&lt;Company Overview&gt;Mensor is based in San Marcos and offers employees work life balance, excellent benefits, casual dress code and tuition reimbursement. We believe in the health and well-being of our employees and offer many wellness activities for our employees to participate in.Since its founding in 1969, Mensor has been dedicated to designing and manufacturing the finest, high-accuracy, pressure measuring, calibration, controlling instruments and test systems available. Mensor has developed an international reputation for quality products and service in the precision pressure instrumentation market.The primary responsibility of the Quality Assurance (QA) Director is to monitor all corporate quality functions, ensuring the integrity of quality programs as they relate to international standards ISO 9001, ISO/IEC 17025, and various international statutory and regulatory requirements. Responsibilities also include acting liaison to the parent company, WIKA, addressing the quality policies, procedures and requirements.&lt;General Responsibilities&gt; The QA Director responsibilities include but are not limited to:<ul><li>Responsibility for supporting the Mensor Management System, Quality Policy, Quality Objectives and adherence to the WIKA Corporate Process Landscape (ref. management manual MM 3.0).</li><li>Direct the creation, implementation, and maintenance of the management system documentation including work instructions, quality system procedures and other documentation relative to ISO 9001 and ISO/IEC 17025 compliance.</li><li>Adherence and compliance to environmental requirements, i.e. RoHS, REACH and Prop 65.</li><li>Monitor the quality control functions of inspection activities and techniques throughout the manufacturing process.</li><li>Develop and maintain quality engineering techniques as required.</li><li>Monitor procedures for handling non-conformances and corrective actions.</li><li>Report performance of suppliers, internal activities and warranties against established targets and goals.</li><li>Monitor and report warranty, production and service quality.</li><li>Perform external audits of current and potential suppliers as required.</li><li>Responsible for implementation, scheduling, and conducting internal audits.</li><li>Coordinate customer audits of the Mensor Management System and facilities.</li><li>Answer to customer surveillance inquiries and agreements.</li><li>Prepare and present annual management reviews per WIKA Corporate and ISO standards&rsquo; requirements.</li><li>Maintain and monitor customer satisfaction and complaints.</li><li>Direct continuous improvement activities including performance tools such as 5S, Kaizen and Six Sigma projects.</li><li>Responsible for the quality assurance of the calibration laboratories as they relate to ISO/IEC 17025 in its entirety (ref. Option A of the standard).</li><li>Oversee proficiency tests as directed by A2LA (American Association for Laboratory Accreditation) and ILAC (International Laboratory Accreditation Cooperation) policies.</li><li>Monitor the calibration of production and inspection gauges and tools.</li><li>Perform other duties as requested by the President in support of the management system.</li></ul>&lt;Physical Requirements&gt; The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of:<ul><li>Use hand to finger, handle, or feel objects, tools or controls;</li><li>Reach with hands and arms;</li><li>Talk and hear;</li><li>Stand, walk and sit;</li><li>Lift and/or move up to 55 pounds;</li><li>Close vision and color dissemination.</li></ul>&lt;Work Environment&gt; The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions to:<ul><li>Occasionally work near moving mechanical parts;</li><li>Occasionally be exposed to risk of electrical shock.</li></ul>&lt;Skills, Knowledge, Abilities&gt; The desired experience and capabilities are:<ul><li>Two years of college in a technical field.</li><li>Three to five years of experience in a quality assurance position.</li><li>High degree of knowledge with ISO 9001.</li><li>High degree of knowledge with ISO/IEC 17025.</li><li>Experienced in audits and conducting audits in a manufacturing and production setting.</li><li>Background in pressure, temperature and electronic instrument manufacturing.</li><li>Experience with inspection tools is a plus (optical comparator, profilometer)</li><li>Good communications and interpersonal skills.</li><li>Ability to use math to solve problems and analyze data.</li><li>Available for limited travel (national and international).</li><li>Ability to prepare detailed written reports.</li></ul>***Please apply directly on the Mensor website at www.mensor.com***Job Type: Full-timeBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Employee assistance program</li><li>Flexible spending account</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Parental leave</li><li>Professional development assistance</li><li>Referral program</li><li>Tuition reimbursement</li><li>Vision insurance</li></ul>Work Location: In person

Director of Quality

Samuel Knight Energy & Infrastructure

<div>
 
 The Director of Data Center Construction Quality is responsible for managing the quality of the project (NTP to COD) to ensure the project is constructed and performs in accordance with the established requirements and standards. The qualified candidate will work closely with the SB Energy Project Manager and the EPC&rsquo;s Quality and Construction Manager to ensure all goals are achieved. The role also includes direct oversight and review of the entire documentation and physical inspection phase of the workflow process and collaborating with other in-house personnel (e.g.: Construction Manager, Project Engineer etc.) and external personnel to produce and document a quality product. This role will report directly to the VP of Operational Excellence and secondary reporting to the VP of Data Center Projects.
 
 
 
 
 
 
 Qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Engineering (Electrical, Mechanical, or Structural required)
 </li>
 <li>
 12+ years in quality, engineering, commissioning, or construction leadership within: Data centers, Semiconductor fabs, Power generation or other mission-critical infrastructure
 </li>
 <li>
 Demonstrated authority interacting with EPCs, designers, and hyperscale clients
 </li>
 <li>
 Proven ability to identify latent defects and systemic risks before they reach operations
 </li>
 </ul>
 
 
 
 
 
 Preferred:
 
 
 
 
 
 <ul>
 <li>
 PE license
 </li>
 <li>
 Commissioning or quality certifications (CxA, PMP, ISO lead auditor, etc.)
 </li>
 <li>
 Experience in design-build and fast-track delivery models
 </li>
 </ul>
 
 
 
 
 
 Technical Requirements
 
 
 
 
 
 <ul>
 <li>
 Mission-critical electrical systems up to and including medium-voltage distribution
 </li>
 <li>
 Mechanical cooling systems for high-density and liquid-cooled environments
 </li>
 <li>
 Redundancy architectures (N, N+1, 2N, distributed redundancy)
 </li>
 <li>
 Commissioning methodologies and failure-mode testing
 </li>
 <li>
 Applicable codes and standards:
 </li>
 <li>
 NEC, NFPA, IBC, IFC
 </li>
 <li>
 IEEE, ASHRAE, ASME
 </li>
 <li>
 Uptime Institute / TIA-942 concepts (formal certification not required)
 </li>
 </ul>
 
 
 
 
 
 SALARY &ndash; 190,000 &ndash; 220,000
 
 
 
 
 
 <ul>
 <li>
 100% Company-Paid Medical, Dental &amp; Vision (for employees and dependents)
 </li>
 <li>
 401(k) with Company Match
 </li>
 <li>
 Generous Paid Time Off + 11 Paid Holidays
 </li>
 <li>
 12 Weeks Paid Parental Leave
 </li>
 <li>
 PLUS MORE
 </li>
 </ul>
 
 
 
 
 
 Location:
 
 San Francisco/Bay Area, CA or TX is preferred. Hybrid.
 
</div>

Director of Quality Assurance

A Hiring Company

<div>
 Description:
 
 
 The Director of Quality is a critical leadership position responsible for establishing, implementing, maintaining, and improving the Quality Management System (QMS) for our FAA Part 145 Repair Station located in Doral, FL. This role ensures strict compliance with all applicable aviation regulations (FAA, EASA, AS9100, etc.), customer requirements, and company policies and has stop/hold authority with direct access to the repair station&rsquo;s Accountable Manager. The Director of Quality will lead all quality assurance and control activities, foster a strong culture of quality and continuous improvement, and safeguard the airworthiness of all repaired aircraft parts and components.
 
 
 
 Requirements:
 
 <ul>
 <li>
 Develop, implement, maintain, and continuously improve the company's Quality Management System, ensuring alignment with FAA Part 145, EASA Part 145, and other relevant regulatory requirements.
 </li>
 <li>
 Serve as the primary point of contact for regulatory agencies (e.g., FAA Principal Maintenance Inspector - PMI) during audits and inspections.
 </li>
 <li>
 Ensure the Repair Station Manual (RSM) and all associated procedures are current, compliant, and effectively implemented.
 </li>
 <li>
 Ensure ongoing compliance with FAA Title 14 CFR Part 145 regulations, including personnel qualifications/training, internal audit programs, maintenance procedures, tooling, and record-keeping.
 </li>
 <li>
 Manage and respond to audit findings, ensuring timely and effective corrective and preventive actions (CAPA).
 </li>
 <li>
 Establish and maintain robust inspection procedures for incoming materials, in-process work, and final outgoing products/components.
 </li>
 <li>
 Oversee the calibration system for all precision tools and equipment.
 </li>
 <li>
 Lead investigations into quality escapes, customer complaints, and reportable incidents, determining root causes and implementing effective corrective actions.
 </li>
 <li>
 Ensure all maintenance, inspection, and quality records are accurately maintained, retrievable, and compliant with Return to Service (RTS) regulatory requirements (e.g., FAA Form 8130-3).
 </li>
 <li>
 Drive continuous improvement initiatives within the QMS and operational processes to enhance efficiency, reduce defects, and improve customer satisfaction.
 </li>
 <li>
 Lead, mentor, and develop the Quality Assurance and Quality Control teams, including inspectors and auditors.
 </li>
 </ul>
 
 Experience and Skills
 
 <ul>
 <li>
 Minimum of 10 years of progressive experience in Quality Management within an FAA Part 145 Repair Station environment.
 </li>
 <li>
 In-depth knowledge of FAA 14 CFR Part 145 and EASA Part 145 regulations is essential.
 </li>
 <li>
 Strong understanding of AS9100 standards and their application in an MRO environment.
 </li>
 <li>
 Exceptional leadership, coaching, and team-building skills.
 </li>
 <li>
 Detail-oriented with a meticulous approach to quality and compliance.
 </li>
 <li>
 Strong ethical compass and commitment to airworthiness and safety.
 </li>
 </ul>
 
 Physical Requirements
 
 <ul>
 <li>
 Sitting, standing or moving for long periods of time
 </li>
 <li>
 Ability to work in an office and repair station environment.
 </li>
 <li>
 Ability to lift at least 25 pounds occasionally.
 </li>
 </ul>
 
 Education
 
 <ul>
 <li>
 College degree is preferred
 </li>
 <li>
 A&amp;P certificate or Repairman Certificate preferred; must be able to obtain Repairman Certificate if needed for RTS authorization.
 </li>
 </ul>
 
 Compensation and Benefits
 
 <ul>
 <li>
 Full Time Salary position commensurate with experience.
 </li>
 <li>
 Benefits include medical/dental/vision, 401(k) matching, PTO/holidays, training budget&nbsp;
 </li>
 </ul>
 
 About Us
 
 
 Cima Aviation, Inc. is an equal opportunity employer. For more information go to our website at https://www.cimaaviation.com/
 
 
</div>

Director of Quality - CIMA Aviation

HCA Healthcare

<div>This position is incentive eligible. 
 
 
<h5 class="jobSectionHeader">Introduction</h5>
Last year alone, HCA Healthcare colleagues invested over 156,000 hours impacting our communities. As a Division Director of Quality and Clinical Analytics with HCA Healthcare, you can be a manager in an organization that is devoted to giving!<h5 class="jobSectionHeader">
Benefits</h5>
HCA Healthcare, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:<ul><li>
Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation.</li><li>
Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more.</li><li>
Free counseling services and resources for emotional, physical and financial wellbeing 
</li><li>
401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service) 
</li><li>
Employee Stock Purchase Plan with 10% off HCA Healthcare stock 
</li><li>
Family support through fertility and family building benefits with Progyny and adoption assistance. 
</li><li>
Referral services for child, elder and pet care, home and auto repair, event planning and more 
</li><li>
Consumer discounts through Abenity and Consumer Discounts 
</li><li>
Retirement readiness, rollover assistance services and preferred banking partnerships 
</li><li>
Education assistance (tuition, student loan, certification support, dependent scholarships) 
</li><li>
Colleague recognition program 
</li><li>
Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence) 
</li><li>
Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.</li></ul>
Learn more about Employee Benefits
Note: Eligibility for benefits may vary by location. 
Come join our team as a Division Director of Clinical Analytics. We care for our communities and employees! HCA Hope Fund in fourteen years reached a historic milestone: $50 million in help to our colleagues in need. Last year, HCA Healthcare and our colleagues donated $13.8 million dollars to charitable organizations. Apply Today!<h5 class="jobSectionHeader">
Job Summary and Qualifications</h5>
We are seeking a Division Director of Clinical Excellence and Safety Analytics. As our new Director, you will be responsible for leading the continuous development of advanced analytics capabilities and uncovering drivers of clinical operations and performance improvement. They will provide oversight and guidance to the Quality and Clinical Leaders throughout the HCA Florida - West Florida Division, which includes 16 acute care hospitals. We are an amazing team that works hard to support each other and are seeking a phenomenal addition like you who feels patient care is as meaningful as we do. Take the next step in your career.
You will be responsible for managing and supporting the analytics for Quality and Patient Safety and Infection Control data analytics. The focus is to support the corporate and division strategic plan and goals, and meet HCA quality objectives and standards. In this regard, s/he will have responsibility for facilitating and coordinating activities in:<ul><li>
Patient safety</li><li>
Process improvement and outcomes management</li><li>
Regulatory readiness to include CMS Conditions of Participation, Agency for Healthcare Administration, and The Joint Commission outcomes</li><li>
Knowledge related to Core Measures and Disease Specific Quality &ndash; Stroke, Sepsis, Perinatal</li><li>
Strategic intelligence to support strategic operational plans</li><li>
Project Management to include weekly, monthly and annual statistics of program performance and opportunities.</li></ul>
Responsibilities:<ul><li>
Facilitating the growth of division and hospital knowledge regarding quality, clinical performance and related areas, including the dissemination of &ldquo;best practices&rdquo; across the division.</li><li>
Gather and analyze healthcare data from multiple sources (e.g. COG Dashboards, clinical operations, occurrence reporting systems, external databases) to extract trends and clinical insights.</li><li>
Develop clear, engaging, and visually compelling presentations tailored to diverse internal audiences</li><li>
Providing for the achievement of business and financial goals through optimal division performance in clinical, quality and patient safety data.</li><li>
Collaborating with and supporting hospital quality, medical staff, risk, safety and infection prevention leaders to achieve top ranking in HCA, national and state publicly reported data initiatives. 
</li><li>
Participating in regular analysis of division quality and risk performance data; planning steps for ongoing improvement.</li><li>
Working with Division VP Quality and Chief Medical Officer to support data analysis, reporting, and outcomes improvement. Contributing ongoing enhancement of division quality reporting methods and dashboards.</li><li>
Continuously monitoring and evaluating quality outcomes for patient care across the division, while noting trends, and identifying and prioritizing opportunities to improve.</li><li>
Staying current with NQF, AHRQ, GWTG, Leapfrog, IHI and other quality performance initiatives.</li><li>
Develop and maintains the Division Analytics Database for Clinical Excellence, Patient Safety/Risk Management, Infection Control, Core Measures and publicly reported measures.</li><li>
Work directly with stakeholders on the design, implementation, and reporting of analytics, supporting data and technical needs, and future enhancement activities.</li><li>
Leads and directs all quality management analytics activities for the division, including clinical excellence, regulatory compliance, risk management and safety, performance improvement, and infection control.</li><li>
Promoting a culture that is positive, values individual strengths, takes risks, and is committed to optimal patient care, safety and compliance with standards.</li><li>
Attending HCA-mandated training and meeting all ethics and compliance standards and requirements. Developing and implementing division level projects as directed by Division CMO and Division VPQ.</li></ul><h6 class="jobSectionHeader">
What qualifications you will need:</h6><ul><li>
Master's degree MHA, MBA, MSN, or related field or higher</li><li>
Current Florida licensure as a Registered Nurse preferred</li><li>
5+ years of experience in Leadership in a clinical and quality improvement setting in a healthcare setting or Acute Care Hospital</li><li>
Previous experience within a multi facility environment preferred</li><li>
Current state licensure in area of practice required</li><li>
Certified Professional in Healthcare Quality (CPHQ) or Certified Professional in Patient Safety (CPPS) required</li><li>
Certification in Information Mgt Systems (CPHIMS), Informatics or Analytics preferred</li></ul>
HCA West Florida is a network of hospitals, surgery centers, physician practices, medical education and training programs. We have a complete continuum of specialized health services that meet the healthcare needs of residents and businesses. In 2020, HCA West Florida had more than 1.5 million patient encounters. We provided an economic impact of more than $2.4 billion. With its founding in 1968, HCA Healthcare created a new model for healthcare in the United States. HCA Healthcare has used combined resources to enhance hospitals, deliver patient-focused care and improve the practice of medicine.
HCA Healthcare has been recognized as one of the World&rsquo;s Most Ethical Companies&reg; by the Ethisphere Institute more than ten times. In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for the delivery of charitable care, uninsured discounts, and other uncompensated expenses.
&Acirc; 
&quot;The great hospitals will always put the patient and the patient's family first, and the really great institutions will provide care with warmth, compassion, and dignity for the individual.&quot;- Dr. Thomas Frist, Sr. 
HCA Healthcare Co-Founder
Become a manager with an organization that invests in your career while giving to the community. We are seeking distinguished applicants for our Division Director of Clinical Analytics opening. Help HCA Healthcare create healthier tomorrows for patients and communities.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.</div>

Division Director of Quality Analytics

Medline Industries

<div>Job Summary
Provides enterprise leadership for a central quality support organization that partners with multiple manufacturing locations to resolve complex quality and compliance issues, lead systematic remediation, CAPA execution, and strengthen manufacturing quality systems and processes.
 
 
This role is accountable for rapid, compliant problem resolution across sites while also driving longer-term capability building, standardization, and quality system maturity.
 
 
Manage people, projects, and priorities to address resource and operational challenges.
 
 
Direct and manage sites during FDA inspections and responses to observations.
 
 
Liaison with site operation management providing input and support to ensure Quality and Compliance requirements are being met. Partners cross-functionally with manufacturing, engineering, regulatory, operations, corporate quality, to increase regulatory compliance.
 
 
Support Quality Systems related activities, analyze problems related to quality/regulatory information, and provide process structure and technical support in solving these problems.
 
 
Provide expertise, counsel and guidance to Quality leadership.
 
 
Manage the Quality data integrity for Medline products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements.
Job Description
MAJOR RESPONSIBILITIES
<ul><li>Lead personnel, activities, and resources for continuous Quality System improvement. Motivate and engage the team and others around the operational excellence vision and ensure execution.
</li><li>Advises leadership to ensure the QMS for assigned departments are in compliance as measured by FDA/ISO/internal audits.
</li><li>Collaborate with cross-functional teams to deploy quality processes and systems. Consult and provide guidance to business partners.
</li><li>Partners with other applicable leaders to ensure a strategic approach to any regulatory audit and related responses.
</li><li>Partners with other applicable leaders to ensure a strategic approach to any regulatory audit and related responses Prepare and deliver Customer presentations
</li><li>Oversee critical Quality systems projects and team that identify, lead and drive opportunities to improve quality systems and develop long-term strategies that support the success of the business.
</li><li>Review and determine the application of various system compliance regulations. Ensure compliance to global regulatory requirements with internal procedures. Identify risk and compliance opportunities.
</li><li>Train and coach personnel and cross-functional teams to deliver optimal results.
</li></ul>Management responsibilities include:
<ul><li>Typically manages through multiple Managers
</li><li>Provide leadership and management to one or more major departments of an operating unit or to a department that has systemwide accountability
</li><li>Strategic, tactical and operational planning (12 + months) for the function or department
</li><li>Direct budgetary responsibility for one or more departments, functions or major projects/programs
</li><li>Interpret and execute policies for departments/projects; develop, recommend and implement new policies or modifications to existing policies
</li><li>Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies
</li></ul>MINIMUM JOB REQUIREMENTS
Education
<ul><li>Bachelor&rsquo;s degree in technical or scientific discipline
</li></ul>Work Experience
<ul><li>Knowledge of Food and Drug Administration (FDA), Quality System Regulations (QSR) and International Organization of Standardization (ISO). Proficiency in Microsoft Suite. Position requires travel up to 20% of the time for business purposes (within state and out of state).
</li></ul>Knowledge / Skills / Abilities
Job Title:
<ul><li>Sr Dir Quality Systems
</li></ul>Job Code:
<ul><li>62398
</li></ul>MINIMUM JOB REQUIREMENTS
<ul><li>Experience leading people and cross functional teams through quality change and continuous improvement.
</li><li>Experience hosting FDA/ISO GMP inspections and regulatory meetings.
</li><li>Experience writing, reviewing, and managing FDA responses
</li><li>Experience with quality systems development and implementation.
</li><li>Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions.
</li><li>Experience in the Medical Device, Pharmaceutical industry, cosmetic, combination product industry.
</li><li>Experience hosting FDA/ISO GMP inspections.
</li><li>Proficiency in analyzing and reporting data to identify issues, trends, or exceptions to drive improvement of results and find solutions.
</li><li>Demonstrated ability to control and coordinate team priorities, concurrent projects, competing priorities and critical deadlines.
</li><li>Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).
</li></ul><div>PREFERRED JOB REQUIREMENTS
Work Experience
<ul><li>8 years or more of managerial experience preferred.
</li><li>10 years or more of related experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products industries preferred.
</li></ul></div>Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education &amp; training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$203,000.00 - $305,000.00 Annual
The actual salary will vary based on applicant&rsquo;s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We&rsquo;re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.</div>

Senior Director of Quality Systems

Philips

<div><h3 class="jobSectionHeader">Job Title
</h3>Director of Quality, Compliance and Audit
<h3 class="jobSectionHeader">Job Description
</h3>The Director of Quality, Internal Audit and Compliance Engineering lead the global Internal Audit program and the shared services Compliance Engineering function across the Philips Quality Enterprise Services organization. Accountable for ensuring proactive compliance with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 9001) through robust quality systems, risk-based methodologies, and engineering-driven problem solving.
This role drives global inspection readiness, systemic issue prevention, and continuous improvement by integrating CAPA, root cause analysis, risk management, and compliance monitoring into a cohesive Compliance Engineering framework.
Your role:
Compliance Engineering
<ul><li>Owns the global Compliance Engineering function, integrating CAPA, root cause analysis, risk management, and systemic issue prevention
</li><li>Drives proactive identification and mitigation of compliance risks across the QMS
</li><li>Ensures robust problem-solving methodologies are consistently applied (e.g., 5 Whys, Fishbone, Fault Tree, statistical analysis)
</li><li>Leads governance forums to review systemic issues, trends, and escalations
</li><li>Ensures CAPA remains effective as a subset of the broader Compliance Engineering framework
</li></ul>Internal Audit &amp; Inspection Readiness
<ul><li>Owns the global internal audit program, including risk-based audit planning
</li><li>Leads mock FDA inspections and enterprise readiness activities
</li><li>Ensures audit findings are effectively addressed, trended, and prevented from recurrence
</li><li>Serves as a key leader during regulatory inspections
</li><li>Manages external audit and compliance engineering vendors
</li><li>Defines scope of work, performance expectations, and SLAs
</li><li>Ensures vendors performance is consistent and adheres to regulatory and Philips requirements
</li><li>Defines auditor qualification, certification, and training requirements
</li><li>Assesses and maintains global auditor competency standards
</li><li>Standardizes audit tools, methodologies, and reporting
</li></ul>KPI &amp; Compliance Performance Management
<ul><li>Establishes and monitors global compliance and quality KPIs
</li><li>Drives advanced data analytics, trend identification, and predictive insights
</li><li>Provides executive-level reporting on compliance and safety risks
</li></ul>People Leadership &amp; Organizational Development
<ul><li>Leads and develops a global team of compliance engineers and audit professionals
</li><li>Ensures appropriate resource allocation, workload balance, and technical capability
</li><li>Builds succession plans and develops specialized compliance and engineering skillsets
</li><li>Ensure team performance and talent retention, as well as improving employee engagement scores
</li><li>Owns annual budget for Internal Audit &amp; Compliance Engineering function
</li><li>Optimizes cost vs. compliance and quality outcomes
</li><li>Aligns resources with enterprise risk and strategic priorities
</li><li>Drives simplification, harmonization, and digitalization of QMS processes
</li><li>Embeds risk-based thinking and preventive quality into business processes
</li><li>Leads enterprise initiatives to transition from reactive CAPA to proactive compliance engineering
</li></ul>You're the right fit if:
<ul><li>You have a minimum of 15+ years of experience in the medical device industry with a strong focus and relevant experience in Compliance Engineering, CAPA, Internal Audit, and Quality Systems
</li><li>You have robust understanding and deep knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001.
</li><li>You have experience supporting regulatory inspections (FDA, Notified Bodies)
</li><li>You have proven functional and strategic leadership in global, matrixed organizations.
</li><li>You have a minimum of a Bachelor&rsquo;s degree (Required) in Engineering, Life Sciences, or related technical field - Master&rsquo;s degree preferred (MBA, MS, or equivalent)
</li><li>You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
</li></ul>How we work together:
We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence (5 days per week) in the company&rsquo;s facilities. Field roles are most effectively done outside of the company&rsquo;s main facilities, generally at the customers&rsquo; or suppliers&rsquo; locations. This is an Office-based role.
About Philips:
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others.
<ul><li>Learn more about our business .
</li><li>Discover our rich and exciting history.
</li><li>Learn more about our purpose.
</li><li>Learn more about our culture.
</li></ul>Philips Transparency Details:
<ul><li>The pay range for this position in Cambridge, MA is $181,00 to $286,960
</li><li>The pay range for this position in Plymouth, MN is $170,00 to $270,900
</li><li>The pay range for this position in Nashville, TN and Orange, OH is $162,00 to $258,000
</li></ul>The actual salary offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
At Philips, it is not typical for an individual to be hired at or near the top end of the pay range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here .
Additional Information:
<ul><li>US work authorization is a precondition of employment. T he company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
</li><li>Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Cambridge, MA, Plymouth, MN, Nashville, TN, Orange, OH.
</li><li>May require travel up to 40%.
</li></ul>#LI-PH1
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.</div>

Director of Quality, Compliance and Audit

University of Maryland Medical System

<div>Job Requirements 
 
Provides organizational leadership and subject matter expertise in quality, safety, and regulatory affairs across all Shore Regional Health entities. Leads efforts to maintain continuous regulatory readiness and compliance with applicable accrediting and regulatory organizations. Collaborates with internal and system-wide partners to ensure alignment with UMMS quality, safety, and regulatory standards. Oversees quality reporting and data integrity to support performance improvement and patient safety. Identifies data-driven opportunities for improvement and partners with leaders to implement effective solutions. 
Primary Responsibilities<ul><li>Develop, implement, and lead organization‑wide regulatory, quality, and patient safety programs to ensure continuous compliance with accreditation standards, Medicare and Medicaid Conditions of Participation and Coverage, and State of Maryland regulatory requirements.</li><li>Serve as the primary organizational liaison to accrediting and regulatory agencies, managing official communication, survey readiness activities, corrective action plans, and regulatory inquiries to ensure timely and accurate responses.</li><li>Lead accreditation and survey readiness efforts, including tracer activities, mock surveys, survey coordination, issue clarification, and development of action plans in collaboration with departmental and physician leaders.</li><li>Oversee quality reporting and performance improvement activities, ensuring data integrity, regulatory compliance, and identification of data‑driven opportunities for clinical and operational improvement.</li><li>Provide subject matter expertise and education to leaders, physicians, and staff on regulatory standards, quality improvement methodologies, patient safety practices, and high reliability principles.</li><li>Evaluate, design, and continuously improve the Quality Improvement and Patient Safety Programs in alignment with national trends, best practices, and evolving regulatory expectations.</li><li>Lead patient safety initiatives, including facilitation of Root Cause Analyses and Failure Mode and Effects Analyses, and oversight of patient safety and quality improvement committees.</li><li>Partner with system and organizational stakeholders, including transformation and performance improvement teams, to support change management, high reliability organizing, and sustainable improvement.</li><li>Provide day-to-day leadership and oversight of quality, safety, and regulatory functions, including direct supervision of quality team members, Patient Safety Coordinator, Infection Prevention, and Clinical Informatics Analyst; establish departmental goals, manage performance, and foster a culture of learning and accountability.</li><li>Oversee policy management and governance processes, ensuring organizational policies are current, compliant, and effectively implemented in partnership with process owners.</li><li>Provide administrative and operational leadership for quality, safety, and regulatory teams, including staff development, goal setting, budget management, and fostering a culture of accountability, learning, and continuous improvement.</li><li>Perform all other duties as assigned.</li></ul> 
Work Experience 
 
Education &amp; Experience - Required<ul><li>Master&rsquo;s degree in health care or business-related field
</li><li>Five years health care experience in a clinical discipline, including at least three years quality, safety, and regulatory affairs experience and/or operations leadership experience (or equivalent)</li></ul> 
Education &amp; Experience - Preferred<ul><li>State of Maryland clinical licensure</li><li>CPHQ and CPPS certification</li></ul>
Knowledge, Skills, &amp; Abilities<ul><li>Knowledge of accreditation standards, Medicare Conditions of Participation, patient safety science, and State licensure regulations.</li><li>Advanced oral and written communication skills; demonstrated skill in collaborating effectively with team members, peers, and executive management</li><li>Ability to challenge and debate issues of importance to the organization, including looking at situations from different viewpoints</li><li>Advanced knowledge of applicable regulatory and accreditation standards, requirements, and issues in health care.</li><li>Ability to effectively delegate responsibilities</li><li>Skill in using a variety of operations performance improvement techniques such as Lean and Six Sigma.</li><li>Experience and advanced skill in facilitating groups</li><li>Strong skills in data analysis and display</li><li>Project management and problem-solving skills</li></ul></div>

Director of Quality, Safety, and Regulatory Programs

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