Senior Quality Engineer
On-site · Minneapolis, Minnesota, United States
Job Summary
Senior Quality Engineer responsible for providing Process/Quality Engineering support in the manufacturing of combination medical devices, ensuring high-quality products from development through production. Lead efforts to reduce manufacturing process defects (scrap, nonconforming material, customer complaints) via root-cause analysis and CAPA; may implement product stops and release criteria. Develop and implement product quality plans, quality specifications, risk analyses, and FMEAs in collaboration with product development teams. Identify critical process steps for monitoring systems to reduce defects, collect and analyze quality metrics, and drive product/process improvements. Create quality tools and training materials; evaluate adequacy and compliance of systems and practices against regulation and company documentation. May serve as an auditor for areas of the quality system (development and manufacturing) and sustain compliance and continuous improvement for 21 CFR Part 4. Lead audits related to 21 CFR Part 4 compliance; perform analyses to identify trends and improvement opportunities; be responsible for final Process Monitor Release for products prior to distribution.
Required Qualifications
- Bachelor’s degree in chemical engineering, chemistry or related field
- Minimum of 5 years of relevant manufacturing experience
- Regulated industry experience
- Knowledge and ability to use statistical methods such as trend analysis, pareto and other charting techniques
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