Senior Supplier Quality Assurance Engineer

The Senior Supplier Quality Assurance (SQA) is responsible for developing and executing supplier quality strategy, ensuring compliance with global regulatory requirements, and improving supplier performance across a diverse supply base. This role leads supplier auditing, qualification, risk management, and issue resolution, partnering closely with Procurement, R&D, Manufacturing, Regulatory Affairs, and other departments within the quality organization.

What You Will Do

Lead supplier quality assurance activities to ensure compliance with internal quality standards and applicable regulations, including ISO 13485, FDA QSR, MDR/IVDR, and other global requirements. Plan and execute supplier audits and assessments, identify systemic gaps, and drive timely, sustainable corrective and preventive actions.

Why It Might Be a Fit

This role requires a strong understanding of quality tools/methodologies, supplier qualification, risk management, and process validation. The individual will serve as the primary escalation point for critical supplier issues and supports major regulatory inspections across the business.

Requirements

• Bachelor’s degree in engineering, Life Sciences, Quality, or related technical field or equivalent combination of education experience.
• Minimum 2 regulated environment such as medical devices, pharmaceutical products, food manufacturing, aerospace, or automotive.
• Minimum 5 years Supplier Quality, Quality Engineering, Supply Chain Quality, or applicable industry experience, and demonstrated use of Quality tools/methodologies
• Some working knowledge of ISO 13485, FDA QSR (21 CFR 820), ISO 14971, and MDR.
• Demonstrated experience participating in, conducting, or leading supplier audits (remote and onsite).
• Proficiency in root cause analysis, CAPA management, risk analysis, and supplier issue resolution.
• Some knowledge of supplier qualification, risk management, and process validation (IQ/OQ/PQ).
• Demonstrated ability to present supplier performance metrics, dashboards, and improvement recommendations to leadership.
• Strong communication and cross-functional leadership skills.
• Ability to manage multiple priorities in a complex, fast-paced environment.
• Ability to travel up to 10% annually, both nationally and internationally.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
• Excellent retirement savings plan with a high employer contribution
• Tuition reimbursement
• Freedom 2 Save student debt program
• FreeU education benefit
• Health and wellness benefits