Quality Assurance Engineer II
Integra LifeSciences · Facility, NJ
QualityFull-time$71k–$98kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Quality Assurance Engineer II will oversee compliance and quality systems for medical device manufacturing at the Plainsboro facility. Primary focus includes reviewing nonconformances and corrective actions, monitoring closure timelines, and ensuring regulatory adherence across FDA, ISO, and international standards.
What they're looking for
- Bachelor's degree in science or engineering discipline
- 3–5+ years quality assurance experience in medical device or pharmaceutical manufacturing
- Knowledge of investigations, root cause analysis, and CAPA systems
- Proficiency with MS Office Suite and statistical software
- Excellent organizational and written communication skills
- Ability to work independently with minimal supervision
What you'll be doing
- Review nonconformance investigations and corrective action plans within defined timeframes
- Track, prioritize, and ensure timely closure of quality system records and complaints
- Provide guidance and training to cross-functional personnel on quality investigations and corrective actions
- Prepare monthly and quarterly quality metrics for management review meetings
- Coordinate with internal departments, vendors, and customers on quality-related activities
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.