Manufacturing Medical Quality Director (Plastics Injection)

About the role

This role leads quality management across all MedTech injection molding operations. The director formulates the overall quality policy, sets stringent quality goals and holds full accountability for quality, while implementing and optimizing a robust Quality Management System.

Key responsibilities

• Formulate the overall quality policy, set quality goals and hold full accountability for quality across all MedTech injection molding operations.
• Implement, maintain and optimize a Quality Management System based on ISO 13485 and FDA 21 CFR Part 820.
• Develop medium-to-long-term quality plans to ensure operational excellence and regulatory compliance.
• Host major quality task forces, coordinate across departments and drive quality improvement and cost-reduction initiatives without compromising medical-grade standards.
• Conduct rigorous product audits and monitor process quality indicators for precision injection molding, ensuring mass-production products meet delivery and quality targets.
• Strengthen internal quality firewalls (e.g., IPQC and advanced containment protocols) to prevent defective products from leaving and to reduce external quality costs.

Required profile

• Bachelor's degree in Mechanical Engineering, Plastics Engineering, Quality Management or a related technical field.
• 15+ years of progressive experience in overall manufacturing quality management, with a deep background in Medical Device Manufacturing and Plastics Injection Molding.
• Solid grasp of MedTech regulatory requirements; familiarity with ISO/TS systems such as ISO 9001, ISO 14001 and automotive standards such as IATF 16949, VDA 6.3 or TS 16949 is highly advantageous.

Required skills

• Highly proficient in ISO 13485 and FDA 21 CFR Part 820.
• Lean Manufacturing or Six Sigma methodology; Green/Black Belt or Lean Practitioner certification is a big plus.

Candidates apply through the recruiter; only shortlisted candidates will be contacted.