Supplier Quality Engineer

Supplier Quality EngineerSupplier 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 & ResponsibilitiesMaintain and update the Approved Supplier List (ASL), including supplier addition, re-approval, suspension, or disqualificationConduct supplier evaluations including quality system assessments, technical capability reviews, and regulatory compliance checksEnsure compliance with ISO 13485, FDA 21 CFR Part 820, and Supplier Quality requirementsCollaborate with Procurement and Operations to ensure only ASL-approved suppliers are used for sourcing and productionDefine PPAP scope and level based on component risk, regulatory impact, and supplier maturityAct as the PPAP focal point for suppliers, ensuring timely and complete submission of PPAP packagesEnsure process validations (IQ/OQ/PQ) are completed when applicable for critical or special processesEvaluate Supplier Change Requests (SCRs) for quality, regulatory, and risk impactParticipate in root cause analysis, CAPA activities, and continuous improvement initiatives as requiredSupport readiness for internal, customer, and regulatory auditsCollaborate with Manufacturing, Engineering, and Supplier Quality teams to resolve quality issues in a timely mannerExperienceStrong hands-on experience in supplier qualification, approval, and lifecycle managementProven 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 componentsWorking knowledge of process validation requirements (IQ/OQ/PQ) for supplier processesStrong understanding of risk-based decision making aligned with ISO 14971 principlesStrong skills in root cause analysis and problem-solving methodologiesFamiliarity with electronic QMS / PLM systems (e.g., TrackWise, Agile, Windchill, SAP)Ability to work effectively with Procurement, Engineering, Manufacturing, QA, and Regulatory AffairsStrong supplier communication skills (technical discussions, expectations, escalation)Ability to manage multiple suppliers and PPAPs simultaneously in a regulated environmentStrong attention to detail and documentation accuracyCompliance-focused mindsetAbility to work independently and escalate issues appropriatelyEffective communication and collaboration skills