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 ...