Quality Assurance Engineer II

Role: Quality Assurance Engineer II supporting the Plainsboro, NJ CMC Quality System. Objectives: ensure compliance, monitor and close NCs and CAPAs, support quality investigations, and facilitate continuous improvement within regulatory frameworks. Responsibilities: perform technical reviews of investigations, track and prioritize CAPAs and NCs, provide guidance and training on investigations, prepare metrics, and ensure documentation completeness. Qualifications: Bachelor's in Science or Engineering; 3-5+ years in QA within medical device or pharma manufacturing; knowledge of investigations, root cause analysis, CAPA systems, and technical writing. Preferred: proficiency with MS Office and statistical software, ability to work independently. High-Value: experience with medical device regulations (FDA, ISO 13485, Medical Device Directive, CMDR), focus on quality system management, and cross-functional collaboration. Work setup: unspecified, with responsibilities centered on site quality systems and compliance.