Engineer II, Quality
Integra LifeSciences · Facility, MA
QualityFull-time$71k–$98kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Quality Engineer II position supporting medical device manufacturing operations at a regulated facility. Responsible for independently managing investigations, CAPAs, validations, and quality system activities while ensuring compliance with FDA, ISO, and cGMP requirements.
What they're looking for
- Bachelor's degree in Engineering or Life Sciences discipline
- Minimum 3 years quality engineering experience in regulated manufacturing (or 1-2 years with Master's)
- Medical device industry and FDA/ISO quality standards experience
- Proficiency with FDA 21 CFR 820, ISO 13485, ISO 9001, and risk management principles
- Experience managing nonconformances, investigations, CAPAs, and validations
- Statistical analysis knowledge; SPC, Minitab, or equivalent tools
- Strong technical documentation interpretation and cross-functional collaboration skills
What you'll be doing
- Own and close investigations, nonconformances, and CAPAs independently with root cause analysis
- Lead or support process, test method, and equipment validation activities
- Execute FMEA and risk management activities for manufacturing and process changes
- Apply statistical tools and data trending to drive process improvements and identify issues
- Support new product introductions and participate in regulatory audits and inspections
Privacy & handoff
This role links to Integra LifeSciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.