Senior Engineer, Supplier Quality

Maintain oversight of the Approved Supplier List (ASL) and support continuous improvement of ASL activities (e.g. form efficiency, review and routing) Independently and / or collaboratively with the Manager, Supplier Quality, as needed or directed, provide guidance to the Enable team on the pathway for Supplier Qualification, consistent with site procedures Lead SCARs and / or Quality Alerts with the Enable team and suppliers to ensure robust documentation and closure Support and lead the scheduling, performance, and / or documentation of on-site and / or remote Quality audits Lead the supplier evaluation and performance documentation (e.g. Supplier Scorecards) Apply a risk-based perspective with an understanding of Critical, Major, Minor, or non-GxP classification, when assessing new or approved suppliers to Enable Create and revise procedures to support the Supplier Management department and Enable Drive or assist, as needed, with the responses and action implementation associated with CAPAs, Nonconformances, Quality Audits, Change Control / Change Management, and other QMS elements Ensure accuracy of all documentation, including traceability or linkage of supplier documentation in both physical and electronic platforms (e.g. paper and SAP) Provide routine updates to department leadership, including escalation of any supplier-related challenges (e.g. component quality concerns) Develop and nurture strong collaborative relationships with the Enable supplier network to support continuous improvement efforts Other duties as assigned Requirements Bachelor’s Degree (minimum) in Science, Health, or Engineering A minimum of six (6) years of experience in a supplier – interacting role within a professional environment with an established QMS A minimum of six (6) years of experience in an FDA (or other Competent Authority) regulated environment Experience navigating Quality, Regulatory, and Industry standards in the medical device or pharmaceutical spaces Experience with ISO standards such as

ISO9001

, ISO13485, ISO17025, or others Experience with regulations such as 21CFR210, 21CFR211, or 21CFR820 Experience with DQ / IQ / OQ / PQ and overall Process Validation (PV) navigation Auditor Certification (e.g. CQA, CMDA) or auditor experience (preferred) Experience with controlled environments, such as controlled room temperature, continuous monitoring, and cleanrooms or clean spaces (preferred) Core Competencies Demonstrates expertise in Supplier Quality Management, including oversight of Approved Supplier Lists, Quality Audits, and Supplier Evaluations. Proficient in navigating FDA regulations and ISO standards within the medical device or pharmaceutical industries. Highest-signal resume keywords Supplier Quality Management FDA Regulated Environment Experience ISO Standards Knowledge Quality Auditing Skills Risk-Based Assessment ATS Optimization Keywords Hard Skills Supplier Qualification Quality Management System (QMS) Process Validation (PV) Supplier Scorecards Corrective and Preventive Actions (CAPA) Nonconformance Management Documentation Accuracy Traceability in Documentation Quality Alerts Management Supplier Evaluation Soft Skills Collaborative Relationship Building Communication with Leadership Problem-Solving Certifications & Qualifications Auditor Certification (CQA, CMDA) Industry Keywords Medical Device Pharmaceutical ISO9001

ISO13485

ISO17025

21CFR210

21CFR211

21CFR820

Controlled Environments Quality Regulatory Standards Tools & Technologies SAP Electronic Documentation Platforms #J-18808-Ljbffr Jobtailor