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