Quality Engineer - Aerospace/Medical Device - Naugatuck, CT

The Quality Engineer 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 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 Quality 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)

Job Offer

On Offer for Quality Engineer:

• 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

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