Quality Engineer- Medical Device- Naugatuck, CT Position Available In Naugatuck Valley Planning Region, Connecticut

Job Description:

The Quality Engineer (Medical Device) will lead qualityinitiatives in a highly regulated, precision manufacturingenvironment, ensuring compliance with ISO 13485 and

FDA 21 CFR

Part820 while driving continuous improvement across processes andsystems. This position offers a clear path to advancement, andoffers outstanding development opportunites. Client Details Myclient is a leading contract manufacturer focused on precisioninjection molding for the medical, pharmaceutical, and lifesciences industries. Known for delivering high-quality, compliantcomponents, they support a range of customers in highly regulatedsectors. They are based out of Naugatuck, CT. Description TheQuality Engineer (Medical Devices) will: Ensure compliance with ISO13485 and

FDA 21 CFR

Part 820 in a regulated manufacturingenvironment Lead and support quality investigations, including rootcause analysis, CAPA, and non-conformances Support and participatein equipment and process validations (IQ/OQ/PQ) Collaborate withengineering and production to resolve product and process qualityissues Develop and implement inspection procedures, quality plans,and related documentation Analyze data using tools like Minitab tomonitor trends and drive continuous improvement Contribute to newproduct introductions by supporting quality planning from prototypeto production Oversee supplier quality activities including audits,incoming inspection, and corrective actions Design and improvegauges, fixtures, and vision system setups for quality assuranceApply statistical methods such as SPC, FMEA, and MSA in dailyquality activities Support internal and external audits, includingregulatory and customer inspections Participate in Lean and SixSigma initiatives, with on-site training and certificationopportunities Profile The successful applicant will have:

Bachelor’s degree in Mechanical Engineering (required) 3-7 years ofexperience in a regulated manufacturing environment (medicaldevice, aerospace, or automotive preferred) Strong knowledge of ISO13485 and FDA QSR (21 CFR Part 820) compliance Experience with rootcause analysis, CAPA, and non-conformance investigationsProficiency in statistical tools and methods (SPC, FMEA, MSA, SixSigma, 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, andelectromechanical components Knowledge of Lean Manufacturing andprocess improvement methodologies Proficiency in Minitab and Excelfor data analysis Strong communication, collaboration, andproblem-solving skills ASQ CQE or Six Sigma certification(preferred but not required) If interested please apply through thelink 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 MasterBlackbelt, with company-sponsored certification Competitive salaryand compensation package Performance-based bonus opportunityComprehensive benefits package including medical, dental, andvision coverage 401(k) plan with employer matching contributionsPaid time off Supportive and collaborative team culture within astable and growing organization Exposure to a variety of qualityengineering responsibilities in a regulated manufacturing settingFlexible start times to accommodate different work/life needs MPIdoes 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 anindividual’s status in any group or class protected by applicablefederal, state or local law. MPI encourages applications fromminorities, women, the disabled, protected veterans and all otherqualified applicants.