RANDSTAD PTE. LIMITED is seeking a Senior Quality Director for Plastics Injection in Singapore, focusing on quality management in MedTech manufacturing. The ideal candidate should possess extensive experience in quality management within the medical device sector, particularly with ISO 13485 and FDA regulations
Job Summary
The role requires formulating overall quality policy and maintaining full accountability for quality management across all MedTech injection molding operations.
Candidates must implement and optimize a robust Quality Management System specifically adhering to ISO 13485 and FDA 21 CFR Part 820 regulations.
The position involves hosting major quality task forces to drive significant quality improvement and cost-reduction initiatives without compromising medical-grade standards.
Matching Summary
Match Score: 85
RANDSTAD PTE. LIMITED is seeking a Senior Quality Director for Plastics Injection in Singapore, focusing on quality management in MedTech manufacturing. The ideal candidate should possess extensive experience in quality management within the medical device sector, particularly with ISO 13485 and FDA regulations.
Skills & Requirements
Must-have
ISO 13485 Quality Management System
FDA 21 CFR Part 820 compliance
Plastics Injection Molding expertise
MedTech manufacturing quality oversight
Process quality indicator monitoring
Nice-to-have
Lean Manufacturing or Six Sigma certification
IATF 16949 automotive standards knowledge
Cost-reduction initiative leadership
Cross-departmental task force coordination
Key Requirements
Bachelor's Degree in Mechanical or Plastics Engineering
15+ years of progressive manufacturing quality management experience
Deep background in Medical Device Manufacturing and Plastics Injection Molding
Extensive hands-on knowledge of MedTech regulatory requirements