Sr. Quality Assurance Engineer (Medical Devices)

Description

• Plan, develop, and implement QA standards, inspection, and testing procedures.
• Support manufacturing operations to ensure product quality and compliance.
• Lead failure investigations, root cause analysis, and CAPA implementation.
• Evaluate vendor quality performance and recommend improvements.
• Review Engineering Change Orders for compliance with quality standards.
• Support customer and regulatory audits and drive closure of findings.
• Manage RMA processes and quality metrics for leadership reporting.
• Support MES configuration to ensure traceability and compliance.
• Collaborate with cross-functional teams for quality input in verification activities.
• Prepare and present quality performance metrics for program reviews.