Quality Process Engineer

Quality Process Engineer

Torrington, CT | On-site | Full-time | $85,000–$120,000

A plastics/medical device manufacturer is hiring a Quality Process Engineer to own injection molding and secondary manufacturing processes with a focus on process capability, product quality, and long-term robustness in a regulated environment. You’ll partner with Quality, Production, Tooling, Maintenance, Engineering, and Program Management on daily operations, NPI, and continuous improvement.

PLASTIC INJECTION MOLDING EXPERIENCE IS REQUIRED. Medical device manufacturing experience is a huge plus.

Relocation assistance available. Visa sponsorship is not available.

What you'll do:

• Develop, optimize, and maintain robust plastic injection molding and secondary processes as process owner for assigned cells and lines
• Define critical process parameters, validated process windows, and process control strategies; monitor performance with SPC and capability analysis
• Lead process validations (IQ/OQ/PQ) and maintain documentation including PFDs, pFMEAs, control plans, work instructions, and validation protocols/reports
• Partner with Quality on ISO 13485 / FDA QSR compliance and support nonconformances, deviations, CAPAs, and customer complaints
• Support NPI from design transfer through production launch, including manufacturability assessments and validation strategy
• Lead continuous improvement on scrap, yield, Cp/Cpk, cycle time, and downtime using Lean, Six Sigma, DMAIC, and 8D
• Troubleshoot molding and manufacturing issues on the floor; train operators, technicians, and inspectors on standardized process practices

What you bring:

• Plastic injection molding experience (required) - tooling, materials, and process variables
• Bachelor’s in Mechanical, Plastics, Manufacturing, Industrial Engineering, or related field preferred; 3–7 years in process/manufacturing engineering
• Medical device or other regulated manufacturing experience (huge plus); working knowledge of ISO 13485 and FDA QSR preferred
• Hands-on experience with IQ/OQ/PQ, SPC, process capability, pFMEAs, and control plans
• Scientific molding principles a plus; strong analytical, floor-presence, and cross-functional communication skills

Pay: $85,000–$120,000. Full-time, on-site in Torrington, CT. Relocation assistance available. Visa sponsorship is not available.