Quality Engineer

Quality Engineer We are seeking a hands-on Quality Engineer to join our manufacturing client located in Watertown, CT. This role supports quality activities across multiple projects, focusing on regulatory compliance, rigorous testing, and documentation.

• Ensure compliance with FDA (21 CFR Part 820), ISO 13485, and other international standards.
• Maintain accurate documentation of testing procedures and results.
• Support internal and external audits.
• Conduct risk assessments and develop mitigation strategies.
• Perform FMEA and root cause analysis; implement CAPA.
• Collaborate with Manufacturing, Supply Chain, and Engineering teams.
• Develop and execute test protocols including IQ, OQ, PQ, and software validation.
• Utilize statistical tools to analyze test results and ensure data reliability.

• Statistical analysis tools (Excel, Minitab)
• Power BI for data visualization
• QMS platforms, CAD software (AutoCAD, Solid Works)
• Root cause analysis tools (Fishbone, 5 Whys)
• ERP systems (SAP, Oracle, Microsoft Dynamics)
• Project management and metrology software

• Bachelor’s degree in Engineering or related field
• 3+ years in a regulated industry and metalworking
• Knowledge of FDA, ISO 13485, and 21 CFR Part 820
• Preferred: CQE, CQA, Six Sigma, ISO 13485 Lead Auditor

Location – Watertown, CT. Direct Hire position – Salary 90 – 120k – DOE. Days/Hours – Monday-Friday, 8:00 AM – 4:30 PM.

Benefits include Medical, Dental, Vision, Life Insurance, 401(k), PTO and more.

Equal Opportunity Employer/Veterans/Disabled. Candidate Privacy Statement. Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable.