Manufacturing Quality Engineer – Medical Devices (3+ yrs exp. req.)

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