Quality Assurance Engineer II
$71.3k - $97.75kIntegra LifeSciences Corporation
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.
Responsibilities
- 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
Requirements
- 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
Compensation: $71,300–$97,750 USD base salary
Vacancy posted 22 days ago
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