Senior Quality Engineer
Core
Drive the transfer of manufacturing processes and products from an established facility to a new manufacturing site in Malaysia, ensuring compliance with ISO 13485 and QMS standards.
Role type
Senior Quality Engineer (Manufacturing Transfer)
Builds
Medical device manufacturing processes and products for global patient care
Domain
Medical Devices / Healthcare Technology
Required skills
ISO 13485 compliance, GMP, process validation (IQ/OQ/PQ), PFMEA, control plans, technical documentation, root cause analysis, CAPA management, risk management, cross-functional collaboration
Preferred skills
Technology/process transfer project experience, regulatory audit participation, product design document familiarity, QMS software proficiency, multicultural team collaboration
Technologies
ISO 13485, QMS, PFMEA, Control Plans, IQ/OQ/PQ protocols
Responsibilities
Develop and maintain quality standards and protocols for manufacturing transfers; Define and implement inspection methods and quality controls; Support Test Method Validation and process validation activities; Coordinate readiness of manufacturing equipment and tooling; Analyze historical quality data and defect trends to mitigate risks; Manage quality issues and nonconformances during transfer builds; Ensure audit readiness and maintain compliant records.
Seniority
Senior, hands-on IC