About this role
<table style="width:696.0px;border-style:hidden;margin-left:auto;margin-right:auto" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr style="height:103.05pt"> <td style="width:7.25in" valign="top"> <p><strong>Location: </strong>Onsite</p> <p><strong>Status Type: </strong>Full Time</p> <p> </p> <p><strong>QUALIFICATIONS</strong></p> <p><strong> </strong></p> <p><strong><u>Required:</u></strong></p> <ul> <li>Bachelor’s Degree in Science, Health, or Engineering</li> <li>A minimum of four years of experience in a supplier – interacting role within a professional environment with an established QMS</li> <li>A minimum of four years of experience in an FDA (or other Competent Authority) regulated environment</li> <li>Experience navigating Quality, Regulatory, and Industry standards in the medical device or pharmaceutical spaces</li> </ul> <p> </p> <p><strong><u>Preferred:</u></strong></p> <ul> <li>Auditor Certification (e.g. CQA, CMDA) or auditor experience</li> <li>Experience with standards such as ISO9001, ISO13485, ISO17025, or others</li> <li>Experience with DQ / IQ / OQ / PQ and overall Process Validation (PV) navigation</li> <li>Experience with controlled environments, such as controlled room temperature, continuous monitoring, and cleanrooms or clean spaces</li> </ul> <p> </p> <p><strong><u>Skills & Competencies:</u></strong></p> <ul> <li>Supplier Corrective Action Request / Report (SCAR) navigation</li> <li>Corrective Action / Preventative Action (CAPA) navigation</li> <li>Nonconformance or Deviation investigations, including Root Cause Analysis (RCA)</li> <li>Experience in Quality Audit response preparation and implementation of Action Items</li> <li>Experience in Change Control / Change Management navigation</li> <li>Experience with regulations such as 21CFR210, 21CFR211, or 21CFR820</li> <li>Technical Writing ability, consistent with Enable and industry expectations</li> <li>Adaptable Communication ability to interact with persons intra- and inter-departmentally, suppliers, and other Enable partners</li> <li>Self-manage, prioritize, and ensure efficient time-management of assigned tasks</li> <li>Employ positive influence to lead suppliers in a parallel path with Enable objectives</li> <li>Demonstrate Business Acumen, including strategic planning and challenge resolution</li> <li>Operate with the highest integrity in representation of the Supplier Management department and Enable</li> </ul> <p><strong> </strong></p> <p><strong><u>Physical Requirements:</u></strong></p> <ul> <li>Work in Quality and Manufacturing departments when required</li> <li>Ability to remain sedentary for extended periods of time</li> <li>Light work that includes moving objects up to 40 pounds</li> <li>Position requires being physically present on the premises during regular company hours or as approved by management</li> <li>Ability to travel approximately 20% as needed</li> </ul> <p> </p> <p><strong>RESPONSIBILITIES</strong></p> <ul> <li>Maintain the Approved Supplier List (ASL) and support ASL activities (e.g. form review and routing)</li> <li>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</li> <li>Navigate SCARs and / or Quality Alerts with the Enable team and suppliers to ensure robust documentation and closure</li> <li>Support the scheduling, performance, and / or documentation of on-site and / or remote Quality audits</li> <li>Support the supplier evaluation and performance documentation (e.g. Supplier Scorecards)</li> <li>Apply a risk-based perspective with an understanding of Critical, Major, Minor, or non-GxP classification, when assessing new or approved suppliers to Enable</li> <li>Create and revise procedures to support the Supplier Management department and Enable</li> <li>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</li> <li>Ensure accuracy of all documentation, including traceability or linkage of supplier documentation in both physical and electronic platforms (e.g. paper and SAP)</li> <li>Provide routine updates to department leadership, including escalation of any supplier-related challenges (e.g. component quality concerns)</li> <li>Develop and nurture strong collaborative relationships with the Enable supplier network to support continuous improvement efforts</li> <li>Other duties as assigned</li> </ul> </td> </tr> </tbody> </table> <p> </p>