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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Pay: $90,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Application Question(s):
- Do you live within a commutable distance to Waterbury, CT or willing to relocate?
- The salary range is $90,000 - $110,000 + Annual Bonus Potential + Benefits. What is your desired salary range?
Education:
- High school or equivalent (Required)
Experience:
- quality in medical-device or ISO 13485 manufacturing : 3 years (Required)
- injection-molding or precision-manufacturing : 3 years (Required)
- customer complaint, CAPA, root-cause & defect investigation : 3 years (Required)
- CMM or vision-system programming : 3 years (Required)
- IQ/OQ/PQ, PPAP, or process validation : 3 years (Required)
- GD&T and statistical analysis : 3 years (Required)
Work Location: In person
