Supplier Quality & Process Validation Engineer

Engineering Quality at the Source | Supplier Quality & Process Validation Engineer

Great products start with great suppliers. We are seeking a driven Supplier Quality & Process Validation Engineer to lead remediation and validation initiatives for contract-manufactured finished medical devices within a highly regulated medical device environment. This role is instrumental in strengthening supplier process controls, improving risk documentation, and ensuring compliance with rigorous quality system standards—all with a clear commitment to patient safety and product quality.

Compensation: Up to $54.00 per hour, depending on experience and qualifications.

(Schedule details will be discussed during the interview process.)

• Lead remediation activities related to supplier quality corrective actions (CAPA) for contract-manufactured finished medical devices
• Review, remediate, and approve supplier Process Failure Mode and Effects Analysis (PFMEA) documentation to newly defined criteria
• Evaluate and approve supplier process validations and inspection validations to meet statistical and regulatory requirements
• Perform change management activities to close gaps in supplier process risk documentation and validation activities
• Collaborate cross-functionally with engineering, quality, and supply chain teams to execute deliverables aligned with business needs
• Partner directly with domestic and international suppliers to drive compliance and continuous improvement
• Support installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and test method validation (TMV) activities
• Ensure adherence to Quality System regulations and internal quality policies in all actions
• Maintain strong documentation practices in support of regulatory and audit readiness

• Bachelor's degree in Engineering
• 1-2 years of experience in a manufacturing or regulated production environment
• Hands-on experience with IQ, OQ, PQ, and test method validation
• Understanding of supplier quality engineering, process validation, and manufacturing risk management
• Knowledge of statistical analysis, Six Sigma methodologies, and structured problem-solving techniques
• Strong communication skills with the ability to work cross-functionally and influence suppliers
• Project management capability with a results-oriented mindset
• Self-driven, proactive approach to learning and executing complex initiatives
• Ability to travel up to 15% (primarily domestic, occasional international travel possible)
• Experience with in the medical device industry or supply chain environment preferred

This opportunity offers a comprehensive benefits package designed to support both your professional growth and personal well-being. Employees have access to medical, dental, and vision insurance, pet insurance, and a 401(k) retirement savings plan. Additional offerings include a Health Savings Account (HSA), Employee Assistance Program (EAP), commuter and parking accounts, AD&D insurance, and employee discount programs through People Perks. These benefits are structured to provide financial stability, healthcare coverage, and work-life balance while contributing to life-impacting medical technology.

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

If you are passionate about supplier quality engineering, process validation, and ensuring excellence in medical device manufacturing, this is your opportunity to make a measurable impact.

Click Apply Now to take the next step in your engineering career.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at  By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners.

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