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

Manufacturing Quality Engineer Medical Devices (3 yrs exp. req.)
Location: Near Waterbury CT
Salary: $90000$110000 Annual Bonus Potential Benefits
Benefits: Medical Dental Vision 401(k) w/match Holidays PTO
Job Type: Full-Time On-site
Typical Hours: MondayFriday 4045 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