Success Measures Successful maintenance of ISO 13485 certification Timely closure and effectiveness of CAPAs Reduction in customer complaints and internal quality issues Successful completion of internal, customer, and certification audits Supplier quality performance improvements On-time completion of Management Reviews and Quality Objectives Requirements: Required Background Bachelor’s degree in engineering, Quality, Manufacturing, Life Sciences, or related field. Technical Expertise: demonstrated experience with: ISO 13485 CAPA systems Internal auditing Risk management (ISO 14971 preferred) Supplier qualification and supplier corrective actions Validation activities (IQ/OQ/PQ) Complaint investigations Document control and change management Physical Requirements · Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing, and repetitive motions.