Plastics Injection Senior Quality Director(Medtech ISO13485)

Full-time Quality Management & Operations

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 out...