Supplier Quality Engineer

Responsibilities

• Review and approve supplier documentation including certifications, validations, and quality records
• Ensure supplier readiness for production launch, including quality systems, and process controls
• Participate in design transfer and process/tool validation activities such as IQ/OQ/PQ, MSA and Statistical analysis
• Sustaining Supplier Quality Management: Manage supplier development and continuous improvement to ensure effective design transfer
• Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
• Lead/Support supplier corrective action activities (SCAR/CAPA) and ensure timely closure
• Conduct supplier performance reviews and drive continuous improvement initiatives
• Support containment, root cause analysis, and resolution of supplier-related quality issues
• Supplier Quality System & Compliance: Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
• Support external and internal audits involving supplier quality systems
• Drive adherence to change notification and supplier control requirements
• Cross-Functional Collaboration: Partner with Contract Manufacturing, Procurement, and Engineering
• Support material nonconformance investigations and disposition decisions
• Provide supplier risk input to project teams and change control processes
• Support supply continuity and risk mitigation strategies
• Writing Test Methods to support Validation

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree.
• 3–5 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
• Strong knowledge of ISO 13485 and medical device regulatory requirements
• Experience with supplier audits, qualification, and risk-based supplier management
• Experience supporting NPI or design transfer activities strongly preferred
• Strong understanding of manufacturing processes, validation, and quality systems

Skills

• Experience with medical device manufacturing and global supply chains
• Familiarity with statistical tools (Minitab), risk analysis (FMEA), and CAPA systems
• Experience in process and tool validation
• Strong technical judgment and problem-solving skills
• Experience leading supplier interactions and driving accountability
• Excellent communication and cross-functional collaboration skills
• Strong root cause analysis and data-driven decision-making capability
• Experience managing multiple priorities in a fast-paced NPI and production environment
• High attention to detail and regulatory compliance mindset
• Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 20% travel

Preferred Certifications

• ISO 13485 Internal Auditor certification preferred.
• ASQ certifications (Supplier Quality Professional, Green Belt, CQE, CQA, or similar) are a plus.