Job SummaryThe Supplier Quality Engineer (SQE) is responsible for ensuring that externally sourced materials, components, and services meet applicable regulatory, quality, and performance requirements for medical device manufacturing. This role partners cross-functionally with Supply Chain, Manufacturing, R&D, and Regulatory Affairs to qualify, monitor, and continuously improve supplier performance in compliance with FDA 21 CFR Part 820 (QMSR), ISO 13485, and other global regulatory standards.
Essential FunctionsSupplier Qualification and Onboarding- Lead supplier selection and qualification activities, including supplier audits (on-site and remote), quality system assessments, and technical capability evaluations.
- Approve supplier validation documentation and quality agreements.
- Establish supplier quality requirements and acceptance criteria.
- Ensure suppliers meet ISO 13485 and FDA QSR/QMSR expectations.
Supplier Auditing and Oversight- Plan and execute supplier audits in accordance with risk-based audit schedules.
- Evaluate compliance to 21 CFR Part 820, ISO 13485, ISO 14971 (as applicable), and ISO 11135/11137 (for sterilization suppliers, if applicable).
- Document audit findings and drive timely corrective actions.
- Assess supplier readiness for regulatory inspections.
Supplier Performance Monitoring- Establish and maintain supplier scorecards and KPIs.
- Analyze supplier quality trends (PPM, NCRs, SCARs, OTD, etc.).
- Drive continuous improvement initiatives with suppliers.
- Conduct quarterly business reviews as needed.
Nonconformance & CAPA Management- Lead supplier corrective action requests (SCARs).
- Investigate supplier-related nonconformances and complaints.
- Perform root cause analysis (5-Why, Fishbone, etc.).
- Verify effectiveness of corrective and preventive actions.
- Escalate critical quality issues appropriately.
Validation and Change Management Support- Support supplier-related validation activities, including process validation (IQ/OQ/PQ), sterilization validation oversight, and packaging validation support.
- Review and approve supplier change notifications.
- Perform risk assessments for supplier changes.
- Ensure proper implementation through change control processes.
- Ensure compliance with biocompatibility, material, and regulatory requirements.
- Support regulatory submissions requiring supplier documentation.
Risk Management- Participate in supplier risk assessments.
- Support DFMEA/PFMEA related to supplied components.
- Ensure critical suppliers are identified and controlled appropriately.
Cross-Functional Collaboration- Partner with Engineering during new product development and with Operations during scale-up and product transfer.
- Provide supplier quality input during design reviews.
- Perform additional job duties as assigned.
Education- Bachelor's degree in biological sciences, engineering, or a related field.
Required Experience & Competencies- Minimum 5 years of quality experience in a regulated industry.
- Strong knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485, Risk Management (ISO 14971), CAPA systems, and supplier auditing practices.
- Experience conducting supplier audits independently.
- Experience managing SCARs and supplier performance metrics.
- Strong technical writing and analytical skills.
- ASQ Auditor or Lead Auditor certification for ISO 13485 preferred.
