Quality Engineer - Medical Device Manufacturing

Join a growing Medical Device Manufacturing CompanyOpportunity to implement change and work with leadershipAbout Our ClientWe are currently partnered up with a growing Medical Device Manufacturing company in their search to add a Quality Engineer to the team due to growth. This position will report up into the Quality Manager and will ideally have 3+ years of related quality engineering work. In addition, the ideal candidate will have experience with FDA regulations, ISO 13485 standards, and medical device quality systems, along with strong problem-solving skills to drive continuous improvement in manufacturing processes. If interested, please read on and apply to the Quality Engineer - Medical Device Manufacturing job based near Torrington, CT.Job DescriptionThe Quality Engineer - Medical Device Manufacturing will be responsible for the following:Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory and quality standards.Collaborate with engineering, production, and regulatory affairs teams to ensure quality is integrated throughout the product lifecycle.Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address product or process nonconformities.Participate in risk management activities, including hazard analysis and FMEA, for product and process development.Support validation activities, including IQ, OQ, and PQ protocols for equipment, processes, and products.Perform incoming inspection, in-process inspection, and final product verification to ensure product compliance.Maintain and review quality documentation, including device history records (DHR), design history files (DHF), and technical files.Participate in supplier qualification, audits, and performance monitoring to ensure incoming materials meet specifications.Monitor and analyze quality data (e.g., complaints, nonconformances, yield trends) to identify opportunities for improvement.Support internal and external audits, including regulatory inspections and notified body assessments 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. The Successful ApplicantThe ideal Quality Engineer - Medical Device Manufacturing will be responsible for the following:Bachelor's degree in Mechanical, Biomedical, Industrial, or Manufacturing Engineering (or related technical discipline).3+ years of quality engineering experience in medical device manufacturing or other regulated industries.Strong knowledge of FDA regulations, ISO 13485, and risk management per ISO 14971.Experience with CAPA, root cause analysis, and statistical process control (SPC).Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).Proficiency with quality tools, inspection techniques, and measuring equipment.Excellent analytical, organizational, and communication skills.ASQ Certified Quality Engineer (CQE) or Six Sigma certification a plus.What's on OfferThe successful Quality Engineer - Medical Device Manufacturing will be rewarded with the following:Base Salary of $80,000-$115,000 depending on experienceBonusPTO401K MatchTuition ReimbursementMedical, Dental, VisionContactErin McQuillanQuote job refJN-082025-6813557