Senior Quality Assurance Engineer

As a Senior Quality Assurance Engineer, you will develop and execute supplier quality strategy, ensuring compliance with global regulatory requirements and improving supplier performance. This role leads supplier auditing, qualification, risk management, and issue resolution, partnering with cross-functional teams. You will serve as the primary escalation point for critical supplier issues and support major regulatory inspections.

Requirements

• Bachelor's degree in engineering, Life Sciences, Quality, or related technical field
• Minimum 2 regulated environment experience
• Minimum 5 years Supplier Quality, Quality Engineering, Supply Chain Quality, or applicable industry experience
• Some working knowledge of ISO 13485, FDA QSR (21 CFR 820), ISO 14971, and MDR
• Demonstrated experience participating in, conducting, or leading supplier audits
• Proficiency in root cause analysis, CAPA management, risk analysis, and supplier issue resolution
• 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

Benefits

• Career development with an international company
• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune