Quality Engineer – Aerospace/Medical Device – Naugatuck, CT Position Available In Naugatuck Valley, Connecticut

Job Description:

The Quality Engineer will lead quality initiatives in a highlyregulated, precision manufacturing environment, ensuring compliancewith ISO 13485 and

FDA 21 CFR

Part 820 while driving continuousimprovement across processes and systems. This position offers aclear path to advancement, and offers outstanding developmentopportunites. Client Details My client is a leading contractmanufacturer focused on precision injection molding for themedical, pharmaceutical, and life sciences industries. Known fordelivering high-quality, compliant components, they support a rangeof customers in highly regulated sectors. They are based out ofNaugatuck, CT.

Description The Quality Engineer will:

Ensurecompliance with ISO 13485 and

FDA 21 CFR

Part 820 in a regulatedmanufacturing environment Lead and support quality investigations,including root cause analysis, CAPA, and non-conformances Supportand participate in equipment and process validations (IQ/OQ/PQ)Collaborate with engineering and production to resolve product andprocess quality issues Develop and implement inspection procedures,quality plans, and related documentation Analyze data using toolslike Minitab to monitor trends and drive continuous improvementContribute to new product introductions by supporting qualityplanning from prototype to production Oversee supplier qualityactivities including audits, incoming inspection, and correctiveactions Design and improve gauges, fixtures, and vision systemsetups for quality assurance Apply statistical methods such as SPC,FMEA, and MSA in daily quality activities Support internal andexternal audits, including regulatory and customer inspectionsParticipate in Lean and Six Sigma initiatives, with on-sitetraining and certification opportunities Profile The successfulQuality Applicant will have: Bachelor’s degree in MechanicalEngineering (required) 3-7 years of experience in a regulatedmanufacturing environment (medical device, aerospace, or automotivepreferred) Strong knowledge of ISO 13485 and FDA QSR (21 CFR Part820) compliance Experience with root cause analysis, CAPA, andnon-conformance investigations Proficiency in statistical tools andmethods (SPC, FMEA, MSA, Six Sigma, etc.) Hands-on experience withmetrology tools (e.g., CMMs, vision systems) Familiarity withequipment and process validation (IQ/OQ/PQ) Experience designinggauges, fixtures, and electromechanical components Knowledge ofLean Manufacturing and process improvement methodologiesProficiency in Minitab and Excel for data analysis Strongcommunication, collaboration, and problem-solving skills ASQ CQE orSix Sigma certification (preferred but not required) Job Offer OnOffer for

Quality Engineer:

Mentorship and on-site Six Sigmatraining from a Certified Master Blackbelt, with company-sponsoredcertification Competitive salary and compensation packagePerformance-based bonus opportunity Comprehensive benefits packageincluding medical, dental, and vision coverage 401(k) plan withemployer matching contributions Paid time off Supportive andcollaborative team culture within a stable and growing organizationExposure to a variety of quality engineering responsibilities in aregulated manufacturing setting Flexible start times to accommodatedifferent work/life needs

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