Principal Engineer, Supplier Quality (Medical Devices)

LMA Recruitment

  • Singapore
  • Temporary
  • Full-time
  • 1 month ago
Join Global Medical Devices Manufacturer in their Supplier Quality team and play a pivotal role in upholding the integrity of their products and services. The Team ensure that every component sourced from external partners meets rigorous regulatory and quality standards throughout the product lifecycle. From supplier qualification to performance monitoring and continuous improvement, our mission is to safeguard patient safety while driving operational excellence.About the RoleAs a Principal Engineer, Supplier Quality , you will be a key leader in ensuring our suppliers meet the highest quality expectations and compliance requirements. You’ll collaborate cross-functionally to drive product excellence, reduce risk, and support innovation. This is a high-impact role where strategic thinking, technical expertise, and leadership come together to deliver tangible results.Key Responsibilities
  • Champion compliance with Good Manufacturing Practices (GMPs) and quality management system requirements for medical devices and medicinal products.
  • Lead corrective and preventive actions (CAPAs), audits, non-conformance management (NCMRs), and complaint investigations.
  • Manage supplier changes and approvals using Production Part Approval Process (PPAP).
  • Serve as a core quality lead on New Product Development (NPD) teams—driving Advanced Product Quality Planning (APQP) deliverables including CTQs, PFMEAs, control plans, IQ/OQ/PQ, and more.
  • Conduct quality system audits and ensure supplier adherence to regulatory requirements including FDA, EU-MDR, ISO 13485, cGMP, and ISO 14971.
  • Drive continuous improvement initiatives and implement new processes and systems across the supplier quality lifecycle.
  • Collaborate with cross-functional teams to proactively reduce patient safety risks and strengthen regulatory compliance.
Qualifications
  • Bachelor's degree in Engineering or Science; an advanced degree is a plus.
  • Minimum of 5 years’ experience in supplier quality, manufacturing quality, or engineering quality—preferably within the medical device industry.
  • Proven expertise in quality tools and methodologies such as APQP, PPAP, SPC, and risk-based sampling plans.
  • Deep understanding of global medical device regulations and quality standards including FDA regulations, ISO 13485, ISO 14971, cGMP, and EU-MDR.
  • Strong leadership and communication skills with the ability to influence and drive quality culture across internal and external stakeholders.

LMA Recruitment