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Supplier Quality Engineer (Medical Device)

Job description

Key Responsibilities:

  • Support daily operations by addressing raw material, process, and product non-conformances.
  • Evaluate and approve new suppliers through audits, capability assessments, and risk evaluations.
  • Ensure suppliers comply with relevant standards such as ISO 13485, FDA 21 CFR Part 820, and MDR.
  • Lead investigations on nonconforming materials and work with suppliers to implement corrective actions.
  • Review supplier CAPA responses and verify their adequacy and effectiveness.
  • Track, analyze, and report supplier performance metrics (e.g. defect rates, complaints per million, on-time delivery).
  • Coordinate with cross-functional teams to resolve recurring material or process quality issues.
  • Plan, conduct, and follow up on supplier audits (on-site or remote) to ensure compliance with QMS requirements.
  • Support customer and regulatory audits related to supplier management.
  • Review supplier change notifications and assess potential quality or regulatory impact.
  • Participate in validation activities for supplier process changes or new materials.
  • Develop and maintain incoming material inspection procedures, sampling plans, and test methods.
  • Maintain accurate supplier quality records and prepare regular performance reports for management review.
  • Support risk management and PFMEA activities related to supplier quality.
  • Ensure proper control and segregation of non-conforming materials.
  • Support internal audits and validation reviews as required.

Key Requirements:

  • Bachelor's Degree in Science, Engineering, or a related field.
  • Minimum 2 years of experience in supplier quality or manufacturing quality roles.
  • Experience in the medical device industry is an advantage.
  • Knowledge of ISO 13485, GMP, and PIC/S standards.
  • Strong analytical, problem-solving, and communication skills.
  • Proactive, independent, and able to collaborate effectively across teams.