Senior Engineer, Supplier Quality

Enable Injections Inc.•Sharonville, OH

1d•Onsite

About The 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.

Requirements

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
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

Nice To Haves

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

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