Role OverviewWe are seeking a Sr. Quality Engineer to support the Unity Diabetes Program at a leading medical device manufacturer in Tempe, AZ. This is an exciting opportunity to partner with engineering and manufacturing teams to ensure quality, compliance, and validation excellence across wafer and sensor manufacturing operations.
What You Will Do
Develop, implement, and maintain quality standards, protocols, and procedures for manufacturing processes and products. Ensure manufacturing processes comply with internal procedures, regulatory requirements, and quality standards.
Why It Might Be a Fit
The ideal candidate will have strong experience supporting process development, equipment validation, quality systems, and manufacturing operations within a regulated medical device environment.
Requirements
- Bachelor's Degree in Engineering, Science, or related technical field plus 4+ years of relevant Engineering and/or Quality experience
- Medical device, regulated manufacturing, or related industry experience
- Experience supporting process validation and manufacturing quality initiatives
- Knowledge of Design Controls, risk management, and quality system requirements
- Experience with nonconformance investigations, CAPA, and change control
- Strong technical writing, documentation review, and compliance assessment skills
- Working knowledge of statistical techniques including DOE, acceptance criteria, and comparison testing
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