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

• 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 ISO
  9001, ISO
  13485, ISO
  17025, or others
• Experience with regulations such as 21
  
  CFR
  210, 21
  
  CFR
  211, or 21
  
  CFR
  820
• 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 clean rooms or clean spaces (preferred)

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.

• Supplier Quality Management
• FDA Regulated Environment Experience
• ISO Standards Knowledge
• Quality Auditing Skills
• Risk-Based Assessment

• 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

• Collaborative Relationship Building
• Communication with Leadership
• Problem-Solving

• Auditor Certification (CQA, CMDA)

• Medical Device
• Pharmaceutical
• ISO
  9001
• ISO
  13485
• ISO
  17025
• 21
  
  CFR
  210
• 21
  
  CFR
  211
• 21
  
  CFR
  820
• Controlled Environments
• Quality Regulatory Standards

• SAP
• Electronic Documentation Platforms