Enable Injections, Inc.

QA Engineer

• 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

Senior Engineer, Supplier Quality