What are the responsibilities and job description for the Senior Quality Assurance Engineer position at Intellectt Inc?
Job Title: Quality Assurance Engineer II
Location: Plainsboro, NJ (On-site)
Duration: 10 Months (Temp to Hire)
Job Summary
Seeking a Quality Assurance Engineer II with 3–5 years of Quality Assurance experience in the Medical Device or Pharmaceutical industry. The ideal candidate will have strong experience with Non-Conformance (NC), CAPA, and Root Cause Investigations. Complaint handling experience is a plus.
Required Skills
- 3–5 years of QA experience in a regulated manufacturing environment
- Strong experience with NC, CAPA, and Root Cause Analysis
- Knowledge of FDA, ISO 13485, ISO 9001, and Quality Systems
- Experience reviewing investigations and ensuring timely CAPA closure
- Technical writing and documentation skills
- Proficiency in Microsoft Office
- Bachelor's degree in Engineering or Science preferred
Responsibilities
- Review and approve Non-Conformance (NC) investigations and CAPAs
- Track and drive timely closure of NCs, CAPAs, and Complaints
- Support root cause investigations and corrective actions
- Ensure compliance with FDA, ISO 13485, ISO 9001, and regulatory requirements
- Prepare quality metrics and support Quality Review meetings
- Provide guidance and training on Quality System processes
- Collaborate with cross-functional teams to resolve quality issues
Preferred
- Medical Device experience (preferred)
- Complaint handling experience (plus)
- TrackWise Digital experience is not required