Engineer III, Supplier Quality

Title: Engineer III, Supplier QualityDescriptionLocation: OnsiteStatus Type: Full TimeQualificationsRequired:Bachelor’s Degree in Science, Health, or EngineeringA minimum of four years of experience in a supplier – interacting role within a professional environment with an established QMSA minimum of four years of experience in an FDA (or other Competent Authority) regulated environmentExperience navigating Quality, Regulatory, and Industry standards in the medical device or pharmaceutical spacesPreferredAuditor Certification (e.g. CQA, CMDA) or auditor experienceExperience with standards such as ISO9001, ISO13485, ISO17025, or othersExperience with DQ / IQ / OQ / PQ and overall Process Validation (PV) navigationExperience with controlled environments, such as controlled room temperature, continuous monitoring, and cleanrooms or clean spacesSkills & CompetenciesSupplier Corrective Action Request / Report (SCAR) navigationCorrective Action / Preventative Action (CAPA) navigationNonconformance or Deviation investigations, including Root Cause Analysis (RCA)Experience in Quality Audit response preparation and implementation of Action ItemsExperience in Change Control / Change Management navigationExperience with regulations such as 21CFR210, 21CFR211, or 21CFR820Technical Writing ability, consistent with Enable and industry expectationsAdaptable Communication ability to interact with persons intra- and inter-departmentally, suppliers, and other Enable partnersSelf-manage, prioritize, and ensure efficient time-management of assigned tasksEmploy positive influence to lead suppliers in a parallel path with Enable objectivesDemonstrate Business Acumen, including strategic planning and challenge resolutionOperate with the highest integrity in representation of the Supplier Management department and EnablePhysical RequirementsWork in Quality and Manufacturing departments when requiredAbility to remain sedentary for extended periods of timeLight work that includes moving objects up to 40 poundsPosition requires being physically present on the premises during regular company hours or as approved by managementAbility to travel approximately 20% as neededResponsibilitiesMaintain 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 proceduresNavigate SCARs and / or Quality Alerts with the Enable team and suppliers to ensure robust documentation and closureSupport the scheduling, performance, and / or documentation of on-site and / or remote Quality auditsSupport 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 EnableCreate and revise procedures to support the Supplier Management department and EnableDrive or assist, as needed, with the responses and action implementation associated with CAPAs, Nonconformances, Quality Audits, Change Control / Change Management, and other QMS elementsEnsure 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 effortsOther duties as assignedNearest Major Market: Cincinnati