Posted August 22, 2026
Senior Engineer, Supplier Qulity - 1st
Kable Workforce Solutions
Cincinnati, OH, US
Full Time
Job Description
Job Description
Job Title: Senior Engineer, Supplier Quality
Location: Cincinnati, OH (on-site)
Senior Engineer, Supplier Quality
Kable Workforce Solutions is hiring a Senior Engineer, Supplier Quality for an established FDA-regulated manufacturer in the Cincinnati area. This role supports the Supplier Quality department in qualifying and maintaining the supplier network and strengthening QMS elements across the site.
What You'll Do
- Maintain oversight of the Approved Supplier List and drive continuous improvement of ASL activities
- Guide the team on supplier qualification pathways, consistent with site procedures
- Lead SCARs and Quality Alerts with internal teams and suppliers through to robust closure
- Schedule, perform, and document on-site and remote quality audits
- Own supplier evaluation and performance documentation, including supplier scorecards
- Apply risk-based assessment (Critical, Major, Minor, non-GxP) to new and approved suppliers
- Create and revise departmental procedures
- Drive responses and action implementation for CAPAs, nonconformances, audits, and change control
- Ensure documentation accuracy and traceability across paper and electronic platforms
- Escalate supplier-related challenges and component quality concerns to leadership
What You Bring
- Bachelor's degree in Science, Health, or Engineering
- 6+ years in a supplier-interacting role within an established QMS
- 6+ years in an FDA (or other Competent Authority) regulated environment
- Medical device or pharmaceutical Quality and Regulatory experience
- ISO standards experience — ISO 9001, ISO 13485, ISO 17025 or similar
- Working knowledge of 21 CFR 210, 211, and/or 820
- DQ / IQ / OQ / PQ and overall Process Validation experience
- SCAR, CAPA, nonconformance investigation and root cause analysis
- Strong technical writing and cross-functional communication
Nice to Have
- Auditor certification (CQA, CMDA) or hands-on audit experience
- Controlled environment experience — cleanrooms, controlled room temperature, continuous monitoring
Details
- Full-time, direct hire, on-site in Cincinnati
- Approximately 20% travel
- Light work, moving objects up to 40 lbs
How to Apply
Submit your resume by clicking "apply now." You'll hear from us within one business day.
Submit your resume by clicking "apply now." You'll hear from us within one business day.
About Kable Workforce Solutions
For over 50 years, Kable Workforce Solutions has connected skilled professionals with leading employers across the region. We believe in people first — helping individuals build lasting careers and helping companies grow through quality, integrity, and partnership.
For over 50 years, Kable Workforce Solutions has connected skilled professionals with leading employers across the region. We believe in people first — helping individuals build lasting careers and helping companies grow through quality, integrity, and partnership.
