Quality Assurance Engineer II

Quality Assurance Engineer II

Provide quality compliance support on all aspects of the Plainsboro, NJ CMC quality system. Monitor, prioritize, and track the timely closure of NCs, CAPAs, and complaints for the Plainsboro Plant facility while ensuring compliance with U.S. FDA, ISO 9001, ISO 13485, the Medical Device Directive, CMDR, and other applicable regulations.

• Perform quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined time frames.
• Ensure investigations and root cause analysis are accurate and complete.
• Maintain an accurate log of Non‑Conformances and CAPAs activities.
• Track, follow‑up, and assist in the timely closure of NCs/CAPAs.
• Provide hands‑on guidance and training to all personnel performing activities within the quality system.
• Ensure documentation is complete before closure.
• Assist the Quality Systems team as needed to investigate Non‑Conformances and ensure proper implementation of CAPAs.
• Prepare monthly and quarterly metrics to present at quality review meetings.
• Interact and coordinate activities with other departments, external vendors, and customers.
• Perform other quality systems related duties as required.

• Bachelor’s Degree in Science (Biology, Chemistry) or Engineering (Biomedical, Mechanical, Chemical, or Electrical) preferred.
• 3 to 5+ years of experience in a quality assurance role for medical device or pharmaceutical manufacturing.
• Demonstrated knowledge of investigations, root cause analysis, quality systems, the CAPA system, and technical writing.
• Excellent organizational and communication skills.
• Proficient with MS Office Suite and statistical software.
• Ability to work independently with minimal supervision.

• Salary range: $71,300.00 – $97,750.00 USD.

• Medical, dental, and vision coverage.
• Life insurance.
• Short‑ and long‑term disability insurance.
• Business accident insurance.
• Group legal insurance.
• 401(k) savings plan.

Integra Life Sciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. All qualified candidates are encouraged to apply.