supplier quality engineer

SaniSure

<div>Job Summary
The Supplier Quality Engineer (SQE) is responsible for ensuring that externally sourced materials, components, and services meet applicable regulatory, quality, and performance requirements for medical device manufacturing. This role partners cross-functionally with Supply Chain, Manufacturing, R&amp;D, and Regulatory Affairs to qualify, monitor, and continuously improve supplier performance in compliance with FDA 21 CFR Part 820 (QMSR), ISO 13485, and other global regulatory standards.
Essential Functions<ul><li>
Supplier Qualification and Onboarding<ul><li>
Lead supplier selection and qualification activities, including:<ul><li>
Supplier audits (on-site and remote)</li><li>
Quality system assessments</li><li>
Technical capability evaluations</li></ul></li><li>
Approve supplier validation documentation and quality agreements</li><li>
Establish supplier quality requirements and acceptance criteria</li><li>
Ensure suppliers meet ISO 13485 and FDA QSR/QMSR expectations<ul><li>
Supplier Auditing and Oversight o Plan and execute supplier audits in accordance with risk-based audit schedules</li></ul></li><li>
Evaluate compliance to:<ul><li>
21 CFR Part 820</li><li>
ISO 13485</li><li>
ISO 14971 (as applicable)</li><li>
ISO 11135 / 11137 (for sterilization suppliers, if applicable)</li></ul></li><li>
Document audit findings and drive timely corrective actions</li><li>
Assess supplier readiness for regulatory inspections<ul><li>
Supplier Performance Monitoring</li></ul></li><li>
Establish and maintain supplier scorecards and KPIs</li><li>
Analyze supplier quality trends (PPM, NCRs, SCARs, OTD, etc.)</li><li>
Drive continuous improvement initiatives with suppliers</li><li>
Conduct quarterly business reviews as needed<ul><li>
Nonconformance &amp;CAPA Management</li></ul></li><li>
Lead supplier corrective action requests (SCARs)</li><li>
Investigate supplier-related nonconformances and complaints</li><li>
Perform root cause analysis (5-Why, Fishbone, etc.)</li><li>
Verify effectiveness of corrective and preventive actions</li><li>
Escalate critical quality issues appropriately</li><li>
Validation and Change Management Support</li><li>
Support supplier-related validation activities, including:<ul><li>
Process validation (IQ/OQ/PQ)</li><li>
Sterilization validation oversight</li><li>
Packaging validation support</li></ul></li><li>
Review and approve supplier change notifications</li><li>
Perform risk assessments for supplier changes</li><li>
Ensure proper implementation through change control processes</li><li>
Ensure compliance with biocompatibility, material, and regulatory requirements</li><li>
Support regulatory submissions requiring supplier documentation<ul><li>
Risk Management</li></ul></li><li>
Participate in supplier risk assessments</li><li>
Support DFMEA/PFMEA related to supplied components</li><li>
Ensure critical suppliers are identified and controlled appropriately<ul><li>
Cross-Functional Collaboration</li></ul></li><li>
Partner with:<ul><li>
Engineering during new product development</li><li>
Operations during scale-up and product transfer</li></ul></li><li>
Provide supplier quality input during design reviews</li></ul></li><li>
Perform additional job duties as assigned.</li></ul>
Education<ul><li>
Bachelor&rsquo;s degree in biological sciences, engineering, or a related field.</li></ul>
Required Experience &amp; Competencies<ul><li>
Minimum 5 years of quality experience in a regulated industry</li><li>
Strong knowledge of: FDA 21 CFR Part 820 (QMSR), ISO 13485, Risk Management (ISO 14971), CAPA systems, Supplier auditing practices</li><li>
Experience conducting supplier audits independently</li><li>
Experience managing SCARs and supplier performance metrics</li><li>
Strong technical writing and analytical skills</li><li>
ASQ Auditor, Lead auditor certification for 13485 preferred</li></ul></div>

Supplier Quality Engineer

Oshkosh Defense

<div>About Oshkosh Defense, an Oshkosh company
Oshkosh Defense stands behind those who dedicate their lives to protecting others. As an industry-leading tactical vehicle manufacturer, every day we strive to meet or exceed our customers' ever-changing needs with next generation defense technologies and advanced systems. We operate with unparalleled commitment to those who depend on our products and services worldwide to perform their missions.
YOUR IMPACT
We are looking for a dynamic Supplier Quality Engineer to launch new suppliers and support the facility into production. As a Supplier Quality Engineer, your mission is to continuously improve safety, quality, business, and manufacturing processes with an emphasis on eliminating process waste. The use of structured quality improvement tools is required through validation of the production processes. You will design new processes and re-engineer existing processes to produce outcomes that meet safety, quality, and business expectations.<ul><li>
Validate production processes to ensure potential failure risks are considered and mitigated on the suppliers FMEA and Process Control Plans</li><li>
Promote SPC and error proofing internally and externally with suppliers where there is risk of common mistakes and/or significant failure</li><li>
Provide support as needed and work with suppliers to prioritize defects using tools such as Pareto charts and trend charts. Apply structured problem-solving methods to identify true root causes and implement effective corrective actions, including fishbone diagrams, 5 Why analysis, histograms, SPC, FMEA, benchmarking, brainstorming, 5S, correlation analysis, error proofing, Cpk, Ppk, corrective action matrices, and continual improvement control plans.</li><li>
Revise procedures to drive process improvement.</li><li>
Investigate/analyze and benchmark industry practices for process validation assessments.</li><li>
Implement effective corrective and preventative actions utilizing structured planning methods.
</li><li>Coordinate and work cross-functionally with Employee Teams, Quality, Engineering, Contracts, Sales and Manufacturing to improve processes. Accurately maintain company records and documents in accordance with policies and procedures.
</li><li>Minimal travel as required. (Once per month on average for a duration of 1-3 days.)</li><li>
Accurately maintain company records and documents in accordance with policies and procedures.</li></ul>
MINIMUM QUALIFICATIONS
<ul><li>Bachelor's Degree in a related field</li><li>
1-3 plus years related work experience</li><li>
Must interpret basic technical drawings including characteristics such as views, title blocks, dimensioning, GD&amp;T symbols, etc. Interpret specification requirements in relation to product and process characteristics</li><li>
Training/experience in the use of statistical techniques and process improvement methods</li></ul>
STANDOUT QUALIFICATIONS
<ul><li>Hold a Six Sigma Green Belt or Black Belt or must acquire within eight months of filling this position</li><li>
ASQ Certified Quality Engineer certification (or equivalent) required within eight (8) months of filling this position</li><li>
Advanced training/experience in the use of statistical techniques and process improvement methods</li><li>
Must interpret basic technical drawings including characteristics such as views, title blocks, dimensioning, tolerancing, GD&amp;T symbols, etc. Interpret specification requirements in relation to product and process characteristics</li><li>
Must have experience with and be able to exhibit the use of structured problem-solving techniques utilizing computer applications</li><li>
MS Windows, Microsoft Word, Microsoft Excel, Microsoft Project, Lotus Notes e-mail, Visio, Statistical software, and JDE experience is recommended and will be mandatory within three (3) months in this position</li></ul>
Pay Range:
$64,500.00 - $103,500.00<div><div><div><div><div><div><div><div>
The above pay range reflects the minimum and maximum target pay for the position across all U.S. locations. Within this range, individual pay is determined by various factors, including the scope and responsibilities of the role, the candidate's experience, education and skills, as well as the equity of pay among team members in similar positions. Beyond offering a competitive total rewards package, we prioritize a people-first culture and offer various opportunities to support team member growth and success.</div></div></div></div></div></div></div></div>
Oshkosh is committed to working with and offering reasonable accommodation to job applicants with disabilities. If you need assistance or an accommodation due to disability for any part of the employment process, please contact us at corporatetalentacquisition@oshkoshcorp.com.
Oshkosh Corporation is a merit-based Equal Opportunity Employer. Job opportunities are open for application to all qualified individuals and selection decisions are made without regard to race, color, religion, sex, national origin, age, disability, veteran status, or other protected characteristic. To the extent that information is provided or collected regarding categories as provided by law it will in no way affect the decision regarding an employment application.
Oshkosh Corporation will not discharge or in any manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with Oshkosh Corporation's legal duty to furnish information.
Certain positions with Oshkosh Corporation require access to controlled goods and technologies subject to the International Traffic in Arms Regulations or the Export Administration Regulations. Applicants for these positions may need to be &quot;U.S. Persons,&quot; as defined in these regulations. Generally, a &quot;U.S. Person&quot; is a U.S. citizen, lawful permanent resident, or an individual who has been admitted as a refugee or granted asylum.</div>

Fluidstack

<div>
 
 About Fluidstack
 
 
 
 We exist to make humanity more free. For most of human history, you farmed or you starved. Technology gave people more time for the things they wanted to do, instead of things they had to do. Powerful AI will be the biggest lever for human choice we've ever built - but only if models are aligned with what humanity actually wants. There are groups building AI who don't share these goals. Whoever deploys frontier compute infrastructure fastest will decide whether AI expands human freedom or shrinks it.
 
 
 We're singularly focused on delivering 10 to 100s of GWs of compute faster than anyone else, rethinking every layer of the stack. We acquire power, design and build data centers, and operate them - with teams spanning hardware and software. Speed and scale are our key differentiators. Come be a part of building civilization-scale infrastructure for AI.
 
 
 
 We hire people who care deeply about this problem space. If that is you, please apply!
 
 
 
 
 About The Role
 
 
 
 We are looking for a Lead Supplier Quality Engineer to ensure the highest standards across our in-house manufacturing operations and external data center construction projects. As a people manager and subject matter expert, you will build and lead a team of quality engineers while sitting at the intersection of manufacturing production and large-scale infrastructure, owning quality from supplier selection through delivery.
 
 
 
 Responsibilities
 
 
 
 
 
 Leadership &amp; Management
 
 
 
 
 <ul>
 <li>
 Lead, mentor, and grow a team of supplier quality engineers across manufacturing and data center infrastructure disciplines
 </li>
 <li>
 Set team priorities, manage workload distribution, and drive a culture of quality and continuous improvement
 </li>
 <li>
 Serve as the organizational subject matter expert (SME) on supplier quality, providing guidance to cross-functional stakeholders including procurement, engineering, and construction teams
 </li>
 <li>
 Represent the supplier quality function in leadership reviews, program planning, and executive escalations
 </li>
 <li>
 Develop and manage KPI's and Metrics
 </li>
 <li>
 Support customer executive business reviews
 </li>
 <li>
 Role reports to VP, supply chain. Communication at the founder level will be required.
 
 
 </li>
 </ul>
 
 
 Supplier Quality &amp; Operations
 
 
 
 
 <ul>
 <li>
 Lead supplier qualification, audits, and ongoing performance management for both manufactured components and data center building materials/systems
 </li>
 <li>
 Develop and enforce quality control plans, inspection criteria, and acceptance standards for in-house production lines
 </li>
 <li>
 Partner with external data center general contractors and subcontractors to establish quality expectations and monitor compliance throughout construction
 </li>
 <li>
 Drive root cause analysis and corrective/preventive action (CAPA) processes for non-conformances across manufacturing and infrastructure suppliers
 </li>
 <li>
 Define and track supplier KPIs (defect rates, on-time delivery, audit scores); escalate and remediate underperforming suppliers
 </li>
 <li>
 Collaborate with procurement and engineering teams during new supplier onboarding and new product/facility introduction
 </li>
 <li>
 Support tier-two supplier development initiatives, including capability assessments and capacity planning
 </li>
 <li>
 Maintain quality documentation in compliance with relevant standards (ISO 9001, IPC, ASHRAE, etc.)
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 8+ years of supplier quality, manufacturing quality, or construction quality engineering experience, with at least 2 years in a lead or management role
 </li>
 <li>
 Demonstrated experience managing and developing engineering teams
 </li>
 <li>
 Familiarity with data center infrastructure (MEP systems, structural, electrical) strongly preferred
 </li>
 <li>
 Proficiency in quality tools: FMEA, control plans, SPC, 8D, PPAP
 </li>
 <li>
 Experience conducting supplier audits and managing corrective action workflows
 </li>
 <li>
 Proven ability to influence without authority across suppliers, contractors, and internal teams
 </li>
 <li>
 Bachelor's degree in Mechanical, Electrical, Industrial Engineering, or related field
 
 
 </li>
 </ul>
 
 Preferred
 
 
 
 <ul>
 <li>
 Experience in hyperscale or cloud infrastructure environments
 </li>
 <li>
 Certified Quality Engineer (CQE) or Six Sigma certification (Black Belt preferred)
 </li>
 <li>
 First principles mentality
 
 
 </li>
 </ul>
 
 Salary &amp; Benefits
 
 
 
 <ul>
 <li>
 Competitive total compensation package (salary + equity).
 </li>
 <li>
 Retirement or pension plan, in line with local norms.
 </li>
 <li>
 Health, dental, and vision insurance.
 </li>
 <li>
 Generous PTO policy, in line with local norms.
 
 
 </li>
 </ul>
 The base salary range for this position is $150,000 - $220,000 per year, depending on experience, skills, qualifications, and location. This range represents our good faith estimate of the compensation for this role at the time of posting. Total compensation may also include equity in the form of stock options.
 
 
 We are committed to pay equity and transparency.
 
 
 Fluidstack is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans&rsquo; status, or any other characteristic protected by law. Fluidstack will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
 
 
 
 You will receive a confirmation email once your application has successfully been accepted. If there is an error with your submission and you
 
 did not
 
 receive a confirmation email, please email careers@fluidstack.io with your resume/CV, the role you've applied for, and the date you submitted your application-- someone from our recruiting team will be in touch.
 
 
 
 Compensation Range: $175K - $250K
 
 
</div>

Supplier Quality Engineer, Lead

Jabil

<div>At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. 
This role is to support a new factory in Prince George, VA (onsite) startup manufacturing large form-factor equipment. The product will be large (shipping container size), heavy (50+ tons), and complex. This position will be part of the core factory startup and onboarding team responsible for building the operations and manufacturing staff, fitting out the building, and creating the process flow/work instructions/etc. from the ground up. Skills to include: panel and point to point wire assembly, Medium Voltage, Low Voltage, and High Power Electronic assemblies.
JOB SUMMARY
Lead the Supplier Quality strategy, conduct PPAPs and audits, oversee receiving inspection, and disposition all potential supplier product quality issues. You will evaluate supplier performance and drive supplier improvement activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
<ul><li>Defines, develops and implements Supply base strategies that drive improvements in supplier selection, development, maturity and performance.
</li><li>Provides regular updates to Quality Engineers, Quality Manager, and plant on the execution of the strategy.
</li><li>Supports NPI activities by adherence to APQP, and leading PPAP activities across the supply base.
</li><li>Ensures that all production critical supplier issues are resolved in a timely manner, and corrective actions are implemented.
</li><li>Monitors supplier performance trends and lead large-scale improvement activities with the supply base. Reports on performance internally, and to customers where applicable.
</li><li>Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
</li><li>Comply and follow all procedures within the company security policy.
</li><li>May perform other duties and responsibilities as assigned.
</li></ul>JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS
<ul><li>Expert in the execution of all elements of PPAP, including MSA, process capability studies, PFMEA, Control Plan, etc.
</li><li>ISO 9001Auditor &amp;/or IATF 16949 Auditor certifications are desired.
</li><li>ASQ certifications are desired.
</li><li>Lean/Six Sigma (Green Belt+) certifications are desired.
</li><li>Strong electro / mechanical background desired.
</li><li>Able to read and interpret mechanical drawings
</li><li>Good understanding of quality systems and commercial regulatory requirements.
 </li><li>Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
</li></ul>EDUCATION &amp; EXPERIENCE REQUIREMENTS
<ul><li>Bachelor&rsquo;s degree required, Bachelor&rsquo;s degree in Engineering preferred.
</li><li>3-5 years of experience in Quality or Manufacturing Engineering
</li><li>Or an equivalent combination of education, training or experience.
</li></ul>What Can Jabil Offer You?
Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:
<ul><li>Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
</li><li>401K Match
</li><li>Employee Stock Purchase Plan
</li><li>Paid Time Off
</li><li>Tuition Reimbursement
</li><li>Life, AD&amp;D, and Disability Insurance
</li><li>Commuter Benefits
</li><li>Employee Assistance Program
</li><li>Pet Insurance
</li><li>Adoption Assistance
</li><li>Annual Merit Increases
</li><li>Community Volunteer Opportunities
</li></ul>The pay range for this role is $79,400 - $142,900. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.
As part of the total rewards package, this position is eligible for a short-term incentive based on performance. In addition, Jabil offers benefits to enhance your health, wealth and resilient self. These include medical, dental, and vision insurance plans; 401(k) retirement plan and employee stock purchase plan; and paid time off. 
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver&rsquo;s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law. 
<h1 class="jobSectionHeader">Accessibility Accommodation
</h1>If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to. 
#whereyoubelong 
#AWorldofPossibilities</div>

Supplier Quality Engineer III

ISUZU

Description
 <div>J OB SUMMARY 
Responsible for supplier quality: ensuring all parts are compliant to Engineering, Packaging, and Quality specifications while meeting cost targets. Ensures supplier quality actions conform to Isuzu Quality and APQP (Advance Product Quality Planning) requirements through supplier audits and visits. 
<div><div><div><div>% of time spent
on each activity 
</div><div>PRINCIPAL DUTIES &amp; RESPONSIBILITIES 
</div></div> 
 
<div><div>30% 
15% 
 15% 
</div><div>1. 
2. 
3. 
</div><div>Reviews and coordinates supplier control plans and processes including Production Part Approval Process. Coordinates and completes supplier process audits. 
Assists in supplier sourcing activities: issuing, tracking, and reviewing Request for Quotation packages, monitoring and evaluating supplier quality systems, and ensuring supplier on-time del ivery. 
Assists Vehicle Quality Engineer with Product Concern Reports (PCR) to suppliers for defective parts. 
</div></div> 
<div><div>15% 
10% 
</div><div>4. 
5. 
</div><div>Coordinates continuous improvement activities relating to supplier part quality and cost. 
Assists with coordinating the flow of documents and information regarding engineering changes, quality requirements, etc. between suppliers and department personnel within Isuzu and ICTA. 
</div></div> 
<div><div>5% 
5% 
5% 
</div><div>6. 
7. 
8. 
</div><div>Assists with updates to the INAC Supplier Quality Manual and Website. 
Participates in internal cross-training opportunites. 
Performs miscellaneous job related duties as assigned. 
</div></div> 
</div></div>ORGANIZATIONAL RELATIONSHIPS 
<ul><li>Reports to: Director, Purchasing
</li>No direct reports 
<li>
</li></ul>EDUCATION, EXPERIENCE &amp; TRAINING 
<ul><li>Bachelors degree in Manufacturing Engineering/Industrial Engineering or equivalent directly related work experience.
</li>Minimum five years experience in supplier quality or related field, preferably in automotive ind ustry 
<li>
</li></ul>KNOWLEDGE 
<ul><li>APQP process/procedures
</li><li>Quality Control techniques
</li><li>Blueprints and engineering drawing
</li><li>Working knowledge of SPC functions
</li>Root Cause analysis techniques; Red X, Six Sigma or other 
<li>
</li></ul>SKILLS &amp; ABILITIES 
<ul><li>Proficient PC skills in Windows applications
</li><li>Excellent written and verbal communication skills
</li><li>Ability to read and interpret engineering drawings and specifications
</li><li>Ability to conduct root cause analysis and countermeasure with closed loop controls.
</li><li>Ability to prepare and conduct training and business and technical meetings/presentations
</li><li>Ability to maintain accurate data files
</li>Effective planning and scheduling techniques 
<li>
</li></ul>PHYSICAL STANDARDS 
The employee must be able to access, enter, and retrieve data using a computer. Occasional reaching, stooping, and lifting of office files, reports or records, typically weighing 5 lbs. or less.
Po sition requires travel with overnight stays.</div>
 Qualifications

Senior Supplier Quality Assurance

Howmet Aerospace

<div><div>Job Summary:</div><ul><li>
Lead and manage the global supplier quality function, ensuring consistent compliance with ISO 9001 and IATF 16949 standards across all supplier operations.</li><li>
Develop, implement and continuously improve supplier quality systems, audits, and performance metrics to drive product quality, risk mitigation, and process reliability.</li><li>
Collaborate cross-functionally with global procurement, engineering, and manufacturing teams to resolve supplier issues, support new product launches, and ensure alignment with customer and regulatory requirements.
</li></ul><div>Key Responsibilities:</div><ul><li>
Develop and implement global supplier quality standards aligned with ISO 9001 and IATF 16949 to ensure consistent quality across the supply base.</li><li>
Lead supplier audits and assessments, including initial qualification, periodic surveillance, and performance evaluations to ensure compliance and continuous improvement.</li><li>
Drive corrective and preventive actions (CAPA) with suppliers for non-conformances, ensuring timely resolution and long-term quality improvements.</li><li>
Establish and monitor supplier quality KPIs, such as PPM, on-time delivery, and audit scores, to track performance and initiate improvement plans.</li><li>
Collaborate with internal teams (procurement, engineering, manufacturing, etc.) to align supplier quality objectives with business and customer requirements.</li><li>
Support new product development (APQP/PPAP) by ensuring supplier readiness, capability studies, and documentation in line with IATF 1649 standards and the organization&rsquo;s specific needs.</li><li>
Manage supplier risk assessments and drive strategic initiatives to mitigate quality risks and ensure supply chain resilience.</li><li>
Provide leadership, training, and mentoring to local Quality teams, fostering a culture of accountability and continuous improvement.</li><li>
Implement, develop, and manage receiving inspection processes to ensure incoming materials meet specifications and support robust quality control at point of entry.</li><li>
Lead and manage supplier-related crisis situations, coordinating rapid containment, root cause analysis, and long-term resolution plans to protect customer satisfaction and business continuity.</li></ul><div>
Basic Qualifications:</div><ul><li>
Bachelor&rsquo;s degree (BS) from an accredited university in Engineering, Quality, Supply Chain, or related technical field.</li><li>
Minimum of 5 years&rsquo; experience in supplier quality or quality management roles within a manufacturing environment.</li><li>
Extensive knowledge of Quality Management Systems such as ISO9001 or IATF16949 and production systems.</li><li>
Proficiency in quality tools and methodologies, including root cause analysis, 8D, CAPA, SPC, and MSA.</li><li>
Demonstrated ability to manage global suppliers and work across cultures, time zones, and functions.</li><li>
Strong leadership and crisis management skills, with track record of resolving complex supplier quality issues.</li><li>
Excellent communication, negotiation, and interpersonal skills to influence both internal stakeholders and external suppliers.</li><li>
Willingness to travel domestic and internationally as needed (typically 20-40%).</li><li>
Employees must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available for this position.</li></ul><div></div><div> 
Preferred Qualifications:</div><ul><li>
Master&rsquo;s degree in related fields.</li><li>
Certified Lead Auditor for ISO 9001, IATF 16949 and/or VDA 6.3.</li><li>
Knowledge and experience in metallurgical processes including casting.</li><li>
Experience managing remote or global teams.</li><li>
Knowledge of Regulatory landscape related to transportation and automotive products.</li><li>
Familiarity with sustainability and compliance standards (e.g., RoHS, REACH, Conflict Minerals).</li><li>
Automotive manufacturing background is preferred.</li><li>
Certification in Six Sigma (Green Belt or higher) or Lean Manufacturing principles.</li></ul></div><div></div>

Global Supplier Quality Manager

Stellar Consulting Solutions, LLC

<div>
 
 
 Role: Supplier Quality Analyst
 
 
 
 
 Location: Irvine, CA(Onsite)
 
 
 
 
 Duration: 6+Months(Contract#w2)
 
 
 
 
 Client: Medical
 
 
 
 
 
 
 Education Bachelor Engineering or Quality
 
 
 Windchill / PLM Will red line Doc's
 
 
 Doc control , Validating systems , Updating supplier change request , reveiwing Quality Agreements
 
 
 
 Job Summary
 
 
 
 The Supplier Quality Analyst is responsible for ensuring that suppliers of materials, components, and services used in medical devices consistently meet quality, regulatory, and risk requirements. This role supports compliance with FDA Quality System Regulation (21 CFR 820), ISO 13485 through supplier performance monitoring, corrective action management, and risk-based supplier controls.
 
 
 
 Key Responsibilities
 
 
 <ul>
 <li>
 Manage and maintain supplier qualification, monitoring, and re-evaluation activities in accordance with 21 CFR 820.50 (Purchasing Controls) and ISO 13485.
 </li>
 <li>
 Monitor supplier quality performance using KPIs such as defect rates, corrective action trends, and supplier risk levels.
 </li>
 <li>
 Maintain approved supplier lists (ASL) and supplier quality records per document control requirements.
 </li>
 <li>
 Issue, track, and evaluate Supplier change requests.
 </li>
 <li>
 Escalate supplier quality risks and support remediation and improvement plans.
 </li>
 <li>
 Review and support supplier-initiated or internally driven changes that may impact product quality or compliance (materials, processes, manufacturing location).
 </li>
 <li>
 Collaborate with Engineering and Regulatory Affairs to assess supplier changes requiring validation, verification, or regulatory impact evaluation.
 </li>
 <li>
 Provide supplier quality input for management reviews and quality metrics.
 </li>
 <li>
 Ensure supplier quality documentation is accurate, complete, and maintained in the electronic Quality Management System (eQMS).
 </li>
 <li>
 Ensure supplier activities comply with internal procedures, regulatory requirements, and quality system expectations.
 </li>
 </ul>
 
 
 Required Qualifications
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Engineering, Quality, or a related field; or equivalent experience.
 </li>
 <li>
 2&ndash;5 years of experience in Supplier Quality, Quality Assurance, or Manufacturing within a medical device or other regulated environment.
 </li>
 <li>
 Working knowledge of 21 CFR 820, ISO 13485, and supplier control requirements.
 </li>
 <li>
 Proficiency in Microsoft Excel and data analysis.
 </li>
 </ul>
 
 
 Key Skills &amp; Competencies
 
 
 <ul>
 <li>
 Strong understanding of regulated quality systems
 </li>
 <li>
 Analytical, detail-oriented problem-solving mindset
 </li>
 <li>
 Clear written and verbal communication
 </li>
 <li>
 Ability to influence suppliers and internal stakeholders
 </li>
 <li>
 Strong organizational and time-management skills.
 </li>
 </ul>
 
 
 
 
 kindly share resume at gaurav@stellarconsulting.com or call me at 678-935-7045 to discuss more!
 
</div>

Supplier Quality Assurance

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9493 supplier quality engineer jobs Near Me

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