PURPOSE OF POSITION: This is a dual opportunity role whose purpose is to support the Supplier Quality department and Enable Injections Inc. (Enable) to maintain and enhance the robustness of the Enable supplier network and Quality Management System (QMS) elements. This role supports the Manager, Supplier Quality in the qualification and maintenance of suppliers and collaborates cross-functionally to complete Quality Actions, where the Supplier Quality team is engaged.
QUALIFICATIONSRequired:- 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
Preferred:- Auditor Certification (e.g. CQA, CMDA) or auditor experience
- Experience with controlled environments, such as controlled room temperature, continuous monitoring, and cleanrooms or clean spaces
Skills & Competencies:- Supplier Corrective Action Request / Report (SCAR) navigation
- Corrective Action / Preventative Action (CAPA) navigation
- Nonconformance or Deviation investigations, including Root Cause Analysis (RCA)
- Experience in Quality Audit response preparation and implementation of Action Items
- Experience in Change Control / Change Management navigation
- Technical Writing ability, consistent with Enable and industry expectations
- Adaptable Communication ability to interact with persons intra- and inter-departmentally, suppliers, and other Enable partners
- Self-manage, prioritize, and ensure efficient time-management of assigned tasks
- Employ positive influence to lead suppliers in a parallel path with Enable objectives
- Demonstrate Business Acumen, including strategic planning and challenge resolution
- Operate with the highest integrity in representation of the Supplier Management department and Enable
Physical Requirements:- Work in Quality and Manufacturing departments when required
- Ability to remain sedentary for extended periods of time
- Light work that includes moving objects up to 40 pounds
- Position requires being physically present on the premises during regular company hours or as approved by management
- Ability to travel approximately 20% as needed
RESPONSIBILITIES- 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
