Supplier Quality Engineer

The Supplier Quality Engineer (SQE) will support supplier quality activities for medical device products by ensuring suppliers meet quality, regulatory, and performance requirements. This role involves supplier qualification, audits, incoming inspection readiness, and ongoing supplier performance management. The ideal candidate has hands-on experience working with global suppliers and a strong understanding of medical device quality systems.

• Support supplier qualification and onboarding activities in compliance with medical device quality requirements.
• Plan and conduct supplier quality audits
  , including on-site audits at domestic and international supplier locations.
• Lead and support supplier qualification, assessment, and approval activities.
• Develop, review, and maintain incoming inspection procedures and acceptance criteria.
• Perform and review First Article Inspection (FAI) and qualification documentation.
• Develop and validate test methods used for incoming inspection and supplier verification.
• Apply statistical tools and data analysis (e.g.,
  Minitab
  ) to evaluate supplier quality performance and trends.
• Consultant supplier performance reviews using quality metrics and scorecards.
• Lead and manage Supplier Corrective Action Requests (SCARs), including root cause analysis and effectiveness verification.
• Collaborate with cross-functional teams including Manufacturing, R&D, Quality, and Supply Chain to resolve supplier-related issues.

• 4–5 years of Supplier Quality experience within the medical device industry
  .
• Proven experience conducting supplier audits and supplier qualification activities.
• Experience working with global suppliers and conducting supplier site visits across the U.S. (and internationally, as needed).
• Strong knowledge of incoming inspection processes and quality control requirements.
• Hands-on experience with First Article Inspection (FAI) and supplier qualification documentation.
• Experience in test method development and test method validation
  .
• Working knowledge of statistical analysis tools
  , including Minitab
  .
• Experience conducting supplier performance reviews and managing quality metrics.
• Demonstrated experience leading and closing SCARs
  .

• Knowledge of FDA QSR, ISO 13485, and related medical device regulations.
• Strong communication skills with the ability to work effectively with suppliers and internal stakeholders.
• Ability to manage multiple priorities in a fast-paced environment.