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Location: Onsite
Status Type: Full Time
QUALIFICATIONS
Required:
- Bachelor’s Degree in Science, Health, or Engineering
- A minimum of four years of experience in a supplier – interacting role within a professional environment with an established QMS
- A minimum of four 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
Preferred:
- Auditor Certification (e.g. CQA, CMDA) or auditor experience
- Experience with standards such as ISO9001, ISO13485, ISO17025, or others
- Experience with DQ / IQ / OQ / PQ and overall Process Validation (PV) navigation
- 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
- Experience with regulations such as 21CFR210, 21CFR211, or 21CFR820
- 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 the Approved Supplier List (ASL) and support ASL activities (e.g. form 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
- Navigate SCARs and / or Quality Alerts with the Enable team and suppliers to ensure robust documentation and closure
- Support the scheduling, performance, and / or documentation of on-site and / or remote Quality audits
- Support 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
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