Senior Engineer, Supplier Quality

Enable Injections, Inc.

Senior Engineer managing supplier quality and compliance at Enable Injections. Overseeing supplier qualifications, audits, and ensuring adherence to regulatory standards and specifications.

Posted 7/24/2026full-timeCincinnati • Ohio • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Supplier Quality Management, including oversight of Approved Supplier Lists, Quality Audits, and Supplier Evaluations. Proficient in navigating FDA regulations and ISO standards within the medical device or pharmaceutical industries.

Highest-signal resume keywords

Supplier Quality ManagementFDA Regulated Environment ExperienceISO Standards KnowledgeQuality Auditing SkillsRisk-Based Assessment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Supplier QualificationQuality Management System (QMS)Process Validation (PV)Supplier ScorecardsCorrective and Preventive Actions (CAPA)Nonconformance ManagementDocumentation AccuracyTraceability in DocumentationQuality Alerts ManagementSupplier Evaluation

Soft Skills

Collaborative Relationship BuildingCommunication with LeadershipProblem-Solving

Tools & Technologies

SAPElectronic Documentation Platforms

Certifications & Qualifications

Auditor Certification (CQA, CMDA)

Industry Keywords

Medical DevicePharmaceuticalISO9001ISO13485ISO1702521CFR21021CFR21121CFR820Controlled EnvironmentsQuality Regulatory Standards

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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
Auditor Certification (e.g. CQA, CMDA) or auditor experience (preferred)
Experience with controlled environments, such as controlled room temperature, continuous monitoring, and cleanrooms or clean spaces (preferred)

Benefits

Comp & perks

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