Quality Engineer — Injection Molding - Medical Device

Our client is a consistently recognized Best Place to Work, known for a collaborative, team-centered culture and a high-quality lifestyle in rural Vermont — close to outdoor recreation, cultural amenities, and strong community resources.

This Quality Engineer serves as the technical lead supporting two medical device manufacturing facilities. The position owns the full lifecycle of quality engineering activities and ensures strict compliance with ISO 13485 and FDA 21 CFR 820 requirements. You’ll act as a deployable quality resource, leading validations, investigations, and process controls across operations.

• Lead complex NC/CAPA investigations using structured root cause methodologies (5-Why, Fishbone, systemic analysis)
• Develop and execute IQ/OQ/PQ validations for molding, secondary operations, and auxiliary processes
• Establish and manage SPC alert thresholds and drive early technical intervention
• Oversee Computer System Validation (CSV) for eQMS and production software
• Manage supplier quality including ASL governance, audits, and SCAR execution
• Conduct MSA / Gage R&R and process capability studies
• Provide the Quality Voice in DFM design reviews
• Support regulatory submissions and technical file integrity
• Act as gatekeeper for tooling and equipment validation release
• Provide technical leadership and training for QA technicians
• Resolve floor quality issues and improve inspection efficiency

• Bachelor’s degree in Engineering (or equivalent experience)
• 4–7+ years in a medical device or FDA-regulated manufacturing environment
• Expert knowledge of ISO 13485, FDA 21 CFR 820, GD&T, MSA
• Proficiency with Minitab, Solid Works, ERP, and eQMS systems
• Strong communication, organization, and multitasking skills
• Team-oriented with a continuous improvement mindset

This position is at our client’s Vermont manufacturing facility.