Supplier Qualification Engineer - Imaging Medical ...

We are seeking a highly motivated Supplier Qualification Engineer to support supplier qualification and ongoing compliance activities for imaging medical devices. This role will work closely with suppliers, manufacturing, quality, and R&D teams to ensure supplier processes, materials, and components meet regulatory, quality, and performance requirements throughout the product lifecycle. Preference will be given to candidates with strong Supplier Quality Engineering (SQE) and Manufacturing Engineering experience within regulated medical device environments and proven proficiency in ISO 13485. Key Responsibilities • Lead and support supplier qualification, onboarding, and re-qualification activities for components, assemblies, and critical processes used in imaging medical devices. • Plan and execute supplier audits, including gap assessments, process capability reviews, and compliance evaluations aligned with ISO 13485 and applicable regulatory requirements. • Review and approve supplier documentation, including process flows, PFMEAs, control plans, validation protocols, and quality agreements. • Support process validation activities (IQ/OQ/PQ) at supplier sites for manufacturing and special processes. • Collaborate with Manufacturing Engineering, R&D, and Quality teams to ensure design transfer and supplier readiness for NPI and sustaining programs. • Drive supplier corrective and preventive actions (SCAR/CAPA) and verify effectiveness. • Monitor supplier performance metrics (quality, delivery, compliance) and support continuous improvement initiatives. • Ensure supplier controls align with risk management requirements (e.g., ISO 14971 where applicable). • Support regulatory inspections and internal audits related to supplier controls and external manufacturing. Required Qualifications • Bachelor's degree in Engineering or a related technical discipline. • 7+ years of experience in Supplier Quality Engineering, Manufacturing Engineering, or related roles within the medical device industry. • Strong working knowledge of ISO 13485 and supplier control requirements. • Hands-on experience with supplier audits, process qualification, and validation activities. • Familiarity with regulated manufacturing environments and quality systems. • Strong analytical, documentation, and communication skills. • Ability to work cross-functionally and directly with external suppliers. Preferred Qualifications • Experience supporting imaging medical devices or complex electromechanical systems. • Knowledge of FDA QSR (21 CFR Part 820) and EU MDR supplier requirements. • Experience with NPI supplier qualification and design transfer. • Certification such as ASQ CQE, CQA, or equivalent. • Experience working with global suppliers and contract manufacturers.

Created: 2026-03-04