Supplier Quality Engineer

Supplier Quality Engineer

Supplier Quality Engineer role requiring strong hands-on experience in supplier qualification, approval, and lifecycle management. The candidate should have proven capability in managing Approved Supplier Lists (ASL), conducting supplier audits, and handling PPAP submissions for medical device components. Requires solid understanding of process validation (IQ/OQ/PQ), risk-based decision-making aligned with ISO 14971, and expertise in root cause analysis. Familiarity with electronic QMS/PLM systems such as TrackWise, Agile, Windchill, and SAP is essential, along with the ability to collaborate across cross-functional teams and manage multiple suppliers in a regulated environment.

Roles & Responsibilities

• Maintain and update the Approved Supplier List (ASL), including supplier addition, re-approval, suspension, or disqualification
• Conduct supplier evaluations including quality system assessments, technical capability reviews, and regulatory compliance checks
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and Supplier Quality requirements
• Collaborate with Procurement and Operations to ensure only ASL-approved suppliers are used for sourcing and production
• Define PPAP scope and level based on component risk, regulatory impact, and supplier maturity
• Act as the PPAP focal point for suppliers, ensuring timely and complete submission of PPAP packages
• Ensure process validations (IQ/OQ/PQ) are completed when applicable for critical or special processes
• Evaluate Supplier Change Requests (SCRs) for quality, regulatory, and risk impact
• Participate in root cause analysis, CAPA activities, and continuous improvement initiatives as required
• Support readiness for internal, customer, and regulatory audits
• Collaborate with Manufacturing, Engineering, and Supplier Quality teams to resolve quality issues in a timely manner

Experience

• Strong hands-on experience in supplier qualification, approval, and lifecycle management
• Proven capability to create, manage, and maintain Approved Supplier Lists (ASL)
• Experience conducting supplier quality system audits (on-site / remote / desktop)
• Hands-on experience leading or reviewing PPAP submissions for medical device components
• Working knowledge of process validation requirements (IQ/OQ/PQ) for supplier processes
• Strong understanding of risk-based decision making aligned with ISO 14971 principles
• Strong skills in root cause analysis and problem-solving methodologies
• Familiarity with electronic QMS / PLM systems (e.g., TrackWise, Agile, Windchill, SAP)
• Ability to work effectively with Procurement, Engineering, Manufacturing, QA, and Regulatory Affairs
• Strong supplier communication skills (technical discussions, expectations, escalation)
• Ability to manage multiple suppliers and PPAPs simultaneously in a regulated environment
• Strong attention to detail and documentation accuracy
• Compliance-focused mindset
• Ability to work independently and escalate issues appropriately
• Effective communication and collaboration skills