Engineer III, Supplier Quality (Cincinnati, OH, US, 45241)

Title: Engineer III, Supplier Quality 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 Nearest Major Market: Cincinnati #J-18808-Ljbffr Cintrifuse