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Twonice logo

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

Twonice
Posted 4 days ago
📦Relocation support
🇺🇸United States
💰$90.0K–$110.0K📁Engineering & Development
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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

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