Supplier Quality Engineer

About the role

We are seeking a detail-oriented Supplier Quality Engineer (SQE) with experience in the medical device, healthcare products, or pharmaceutical industry to ensure the quality, compliance, and performance of suppliers throughout the supply chain. The ideal candidate will be responsible for supplier qualification, supplier audits, quality improvement initiatives, incoming quality management, and ensuring compliance with regulatory and quality requirements including ISO 13485, FDA 21 CFR Part 820, ISO 14971, and GMP.

Key responsibilities

• Lead supplier qualification, approval, and onboarding activities to ensure compliance with company and regulatory requirements.
• Conduct supplier risk assessments and establish supplier quality agreements.
• Monitor supplier performance through key quality metrics, including PPM, SCAR closure, on-time delivery, audit performance, and non-conformance trends.
• Develop and maintain approved supplier lists (ASL).
• Plan, perform, and lead supplier audits to assess compliance with ISO 13485, GMP, FDA QSR, and company quality requirements.
• Lead Supplier Corrective Action Requests (SCAR) investigations and resolution activities.
• Conduct root cause analysis using quality tools such as 5 Whys, Fishbone Diagram, and Fault Tree Analysis.
• Manage supplier-related non-conformances and material quality issues.
• Drive supplier quality improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
• Maintain supplier quality records in accordance with QMS requirements.

About you

• Bachelor's Degree in Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Engineering, Life Sciences, or related discipline.
• 3-8 years of experience in Supplier Quality Engineering, Quality Engineering, or Supplier Development within Medical Devices, Healthcare Products, Electronics Manufacturing, or Pharmaceutical industries.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, GMP, and Supplier Quality Management Systems.
• Experience conducting supplier audits and managing supplier corrective actions.
• Strong root cause investigation and problem-solving skills.
• Experience with incoming quality control, supplier qualification, and supplier performance monitoring.
• Knowledge of quality tools and methodologies: SPC, CAPA, 8D, 5 Why Analysis, Fishbone Analysis, FMEA, Six Sigma.
• Preferred: ASQ Certified Quality Engineer (CQE).
• Preferred: Six Sigma Green Belt or Black Belt certification.
• Preferred: Experience with Class II/III Medical Devices.