MANAGER, SUSTAINING QUALITY ASSURANCE ENGINEERING

Responsibilities

• Provide escalation support for significant quality issues
• Ensure timely assessment and containment of quality event
• Participate in MRB activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material
• Own and oversee quality input to post-release design and process changes (ECOs, deviations, waivers, temporary changes)
• Ensure thorough change impact assessments are performed to determine verification, validation, revalidation, and documentation requirements
• Ensure appropriate risk controls, benefit-risk justifications, and verification activities are implemented and documented
• Ensure sustained compliance with applicable regulations and standards, including ISO 13485, FDA 21 CFR 820 (QSR), EU MDR (as applicable), and relevant IEC standards (e.g., IEC 60601-1)
• Collaborating with Supplier Quality and Supply Chain leadership on supplier-related quality issues