Quality Manager(ISO13485 Medical Device-Plastics Injection)

about the company

My client is a contract manufacturer. They’re looking for a Quality Assurance Manager to join their quality team. This role will be reporting to the GM.

about the job

• Direct daily QA operations for consumer products and assembly
• Manage the departmental budget and define quality objectives
• Train and develop Quality Engineers, Supervisors, and Inspectors
• Implement and maintain compliance with ISO 9001, ISO 13485 (QMS), and ISO 14001 (EMS).
• Review and approve risk management and quality planning documents (PFMEA, Control/Inspection Plans)
• Lead the investigation and resolution of internal defects and customer complaints
• Conduct supplier audits and support supplier quality improvement activities
• Manage First Article Inspections (FAI) and process validation with Engineering
• Monitor quality performance metrics and drive continuous improvement initiatives

job requirement

• Degree in quality / engineering or equivalent
• Min 8 years of experience in high volume manufacturing environment for medical devices
• Extensive knowledge in plastics injection molding
• Demonstrated capability in executing production line testing, planning incoming inspections, utilizing electronic QMS platforms, and managing CAPA investigations
• Proficient in advanced quality engineering methodologies, including SPC, FMEA, DOE, MSA, and GR&R
• Deep understanding and practical application of industry standards such as FDA 21 CFR Part 820, ISO 13485, IEC 60601-1, IEC 62304, Design Controls, and Risk Management

If you are interested in the position
Please include your availability, expected salary and reason for leaving current job
We regret that only shortlisted candidates will be contacted
EA: 94C3609 / Reg: R1325913