Supplier Quality Engineer

Job Summary

• 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 escalates issues appropriately
• Effective communication and collaboration skills