Manufacturing Quality Engineer – Medical Devices (3+ yrs exp. req.)
Location: Near Waterbury, CT
Salary: $90,000–$110,000 + Annual Bonus Potential + Benefits
Benefits: Medical, Dental, Vision, 401(k) w/match, Holidays, PTO
Job Type: Full-Time | On-site
Typical Hours: Monday–Friday, 40–45 hours per week
Start Date: ASAP
Sponsorship is not available
Relocation assistance is available

Manufacturing Quality Engineer – Medical Devices Description

Our client in precision manufacturing is looking for a Manufacturing Quality Engineer near Waterbury, CT. You will lead customer quality investigations, support process validation, and improve inspection methods for regulated, precision-molded components. You will work closely with engineering, manufacturing, quality, and metrology teams. This hands-on role includes measurement programming, root-cause analysis, statistical studies, and new-product quality support. To qualify, you must have medical-device manufacturing or ISO 13485 experience. You must also understand injection molding or a comparable precision-manufacturing process. This role offers ownership of varied technical projects and a potential path into quality management, regulatory affairs, or another leadership position.

Manufacturing Quality Engineer – Medical Devices Responsibilities

•    Lead customer complaint, containment, and corrective-action activities 
•    Communicate investigation findings and preventive actions to customers 
•    Perform root-cause analysis and verify long-term corrective actions 
•    Support IQ, OQ, PQ, PPAP, first-article, and product-launch activities 
•    Create and analyze CMM or vision-system inspection programs 
•    Develop control plans, inspection templates, and measurement methods 
•    Apply GD&T when planning measurements, fixtures, and inspection methods 
•    Conduct capability studies, GR&R, DOE, and other statistical analyses 
•    Support inspectors and metrologists with training and troubleshooting 
•    Recommend equipment and automation to improve inspection throughput 
•    Design or define gauges, fixtures, and inspection tooling 
•    Lead projects that reduce scrap, process variation, labor, and COPQ 

Manufacturing Quality Engineer – Medical Devices Qualifications

•    3+ years of quality experience in medical-device or ISO 13485 manufacturing required
•    Injection-molding or precision-manufacturing experience required
•    Customer complaint, CAPA, root-cause, and defect investigation experience required
•    CMM or vision-system programming experience required
•    IQ/OQ/PQ, PPAP, or process validation experience required
•    Proficiency with GD&T and statistical analysis required