Opportunity Description
Key Responsibilities
- Formulate the overall quality policy, set stringent quality goals, and maintain full accountability for quality management across all MedTech injection molding operations.
- Implement, maintain, and optimize a robust Quality Management System (specifically ISO 13485 and FDA 21 CFR Part 820). Develop medium‑to‑long‑term quality plans to ensure continuous operational excellence and regulatory compliance.
- Host major quality task forces, coordinate across departments, and drive significant quality improvement and cost‑reduction initiatives without compromising medical‑grade standards.
- Conduct rigorous product audits and effectively monitor process quality indicators for precision injection molding. Ensure that all products transitioning into mass production meet strict delivery and quality targets.
- Strengthen internal quality firewalls (such as IPQC and advanced containment protocols) to strictly block the outflow ...
Ready to Apply?
Submit your application for Plastics Injection Senior Quality Director(Medtech ISO13485) at Randstad
Apply for this Position