Sr Quality Engineer
Job in
Tempe, Maricopa County, Arizona, 85285, USA
Listed on 2025-12-21
Listing for:
Katalyst CRO
Full Time
position Listed on 2025-12-21
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer, Process Engineer, Biomedical Engineer
Job Description & How to Apply Below
4 days ago Be among the first 25 applicants
Responsibilities and Qualifications- We are seeking a Senior Quality Engineer to support process development, manufacturing quality, and compliance for implantable cardiac and neuromodulation medical devices.
- This role focuses on inspection optimization, process and test method validation, and continuous improvement within a regulated medical device manufacturing environment.
- Lead Inspection Optimization projects (manual, automated, and semi-automated inspection)
- Support equipment development, IQ/OQ/PQ, process characterization, and validation
- Develop and execute Test Method Validation (TMV), including Gage R&R / MSA
- Ensure compliance with FDA, ISO, and GMP quality requirements
- Support CAPA, nonconformance investigations, change control, and risk management (pFMEA/dFMEA)
- Drive quality metrics, scorecards, and continuous improvement initiatives
- Collaborate cross-functionally with manufacturing, process, and design teams.
- Education & Experience:
- Bachelor's degree in Engineering with 4+ years' experience (or Master's with 2+ years).
- Strong experience in medical device manufacturing quality. Hands‑on knowledge of IQ/OQ/PQ, TMV, DOE, SPC, and statistical analysis.
- Expertise in structured problem solving (DMAIC, 8D, Ishikawa).
- Excellent technical documentation and communication skills. Proficiency with Microsoft Office tools.
- Experience in microelectronics/electronics manufacturing (SMT, wafer, IC assembly).
- Experience supporting FDA, MDSAP, or TUV audits.
Associate
Employment typeContract
Job functionQuality Assurance
IndustriesPharmaceutical Manufacturing
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