Quality Engineer – Med-Device Manufacturing, ISO 13485 (3+ yrs exp. req. / Waterbury
Listed on 2026-08-04
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Quality Assurance - QA/QC
Quality Engineering, Production QC/QA
Manufacturing Quality Engineer – Medical Devices (3+ yrs exp. req.)
Location:
Near Waterbury, CT
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 DescriptionOur 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.
- 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
- 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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