Massachusetts Licensed Quality Engineer
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Job Summary
Leading quality improvement initiatives, the full-time Massachusetts Licensed Quality Engineer will develop and implement processes for Class III medical devices, oversee product validations, and ensure compliance with regulatory standards while working in a hybrid remote setting.
Key responsibilities
- Develop and implement manufacturing process changes and product design improvements for medical devices
- Conduct internal and external product and process validations, ensuring compliance with quality standards
- Analyze data using statistical tools to identify trends and develop innovative solutions for quality issues
Required qualifications
- U.S. Master's degree in Industrial/Manufacturing Engineering or related discipline, plus 2 years of relevant experience
- Experience with manufacturing process validation and Good Manufacturing Practices (GMP)
- Proficiency in statistical tools such as control charts, Pareto charts, and Six Sigma methodology
- Knowledge of structured manufacturing frameworks, including APQP and PPAP
- Experience in risk analysis, FMEA, and vendor quality evaluation
Complete Job Description
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