Quality Engineer- Medical Device- Naugatuck, CT

Location: Naugatuck
Posted on: June 23, 2025

Job Description:

The Quality Engineer (Medical Device) will lead quality initiatives in a highly regulated, precision manufacturing environment, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 while driving continuous improvement across processes and systems. This position offers a clear path to advancement, and offers outstanding development opportunites. Client Details My client is a leading contract manufacturer focused on precision injection molding for the medical, pharmaceutical, and life sciences industries. Known for delivering high-quality, compliant components, they support a range of customers in highly regulated sectors. They are based out of Naugatuck, CT. Description The Quality Engineer (Medical Devices) will: Ensure compliance with ISO 13485 and FDA 21 CFR Part 820 in a regulated manufacturing environment Lead and support quality investigations, including root cause analysis, CAPA, and non-conformances Support and participate in equipment and process validations (IQ/OQ/PQ) Collaborate with engineering and production to resolve product and process quality issues Develop and implement inspection procedures, quality plans, and related documentation Analyze data using tools like Minitab to monitor trends and drive continuous improvement Contribute to new product introductions by supporting quality planning from prototype to production Oversee supplier quality activities including audits, incoming inspection, and corrective actions Design and improve gauges, fixtures, and vision system setups for quality assurance Apply statistical methods such as SPC, FMEA, and MSA in daily quality activities Support internal and external audits, including regulatory and customer inspections Participate in Lean and Six Sigma initiatives, with on-site training and certification opportunities Profile The successful applicant will have: Bachelor's degree in Mechanical Engineering (required) 3-7 years of experience in a regulated manufacturing environment (medical device, aerospace, or automotive preferred) Strong knowledge of ISO 13485 and FDA QSR (21 CFR Part 820) compliance Experience with root cause analysis, CAPA, and non-conformance investigations Proficiency in statistical tools and methods (SPC, FMEA, MSA, Six Sigma, etc.) Hands-on experience with metrology tools (e.g., CMMs, vision systems) Familiarity with equipment and process validation (IQ/OQ/PQ) Experience designing gauges, fixtures, and electromechanical components Knowledge of Lean Manufacturing and process improvement methodologies Proficiency in Minitab and Excel for data analysis Strong communication, collaboration, and problem-solving skills ASQ CQE or Six Sigma certification (preferred but not required) If interested please apply through the link below. Qualified applicants will be contacted within 24 hours. Job Offer The Quality Engineer (Medical Devices) will receive: Mentorship and on-site Six Sigma training from a Certified Master Blackbelt, with company-sponsored certification Competitive salary and compensation package Performance-based bonus opportunity Comprehensive benefits package including medical, dental, and vision coverage 401(k) plan with employer matching contributions Paid time off Supportive and collaborative team culture within a stable and growing organization Exposure to a variety of quality engineering responsibilities in a regulated manufacturing setting Flexible start times to accommodate different work/life needs MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Keywords: , New England , Quality Engineer- Medical Device- Naugatuck, CT, Engineering , Naugatuck, Northeast