Plastics Injection Senior Quality Director(Medtech ISO13485)
This senior leadership role focuses on managing quality policy and compliance for MedTech injection molding operations. The candidate will oversee a robust Quality Management System including ISO 13485 and FDA 21 CFR Part 820 standards. Responsibilities include driving operational excellence, auditing product quality, and mitigating manufacturing risks. The role requires extensive experience in quality management and specific expertise in medical device standards.
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Experience
15+ years
Function
Quality Assurance
Work mode
Onsite, Singapore
Company
Tier 3
What you will work on
This senior leadership role focuses on managing quality policy and compliance for MedTech injection molding operations. The candidate will oversee a robust Quality Management System including ISO 13485 and FDA 21 CFR Part 820 standards. Responsibilities include driving operational excellence, auditing product quality, and mitigating manufacturing risks. The role requires extensive experience in quality management and specific expertise in medical device standards.
TAL's take
Senior director role in a specialized niche, but posted by a recruiting firm rather than the end employer.
Extremely clear and specific requirements regarding regulatory standards and manufacturing processes.
Must haves
- Bachelor's degree in Engineering or related field
- 15+ years experience in manufacturing quality management
- Deep background in medical device manufacturing
- Deep background in plastics injection molding
- Hands-on knowledge of ISO 13485
- Hands-on knowledge of FDA 21 CFR Part 820
- Grasp of Lean Manufacturing or Six Sigma
Tools and skills
Nice to have: iso 9001, iso 14001, iatf 16949, vda 6.3, ts 16949, green belt, black belt.
About the company
Staffing and recruitment agency.
Posts mentioning Randstad Singapore
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