Quality Assurance Engineer II

INTEGRA LIFESCIENCES CORP; Plainsboro Township (NJ); On-site; USD 71,300 - 97,750; Full time

Benefits offered by this job

Medical coverage

Dental and vision coverage

Life insurance

Short‑ and long‑term disability insurance

401(k) savings plan

Job summary

INTEGRA LIFESCIENCES CORP is seeking a Quality Assurance Engineer II in Plainsboro, NJ to provide quality compliance support on all aspects of the CMC quality system. The role involves monitoring Nonconformances and ensuring compliance with regulatory standards.

Candidates should have a Bachelor’s Degree in Science or Engineering and 3 to 5+ years of relevant experience in quality assurance for medical devices or pharmaceuticals. Benefits include medical coverage, life insurance, and a 401(k) plan.

Qualifications

• 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.

Responsibilities

• Perform quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined timeframes.
• Ensure investigations and root cause analysis are accurate and complete.
• Maintain an accurate log of Non‑Conformances and CAPAs.
• 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.
• 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.

Skills

Investigations

Root cause analysis

Quality systems

CAPA system

Technical writing

MS Office Suite

Statistical software

Organizational skills

Communication skills

Education

Bachelor’s Degree in Science or Engineering

Job description

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.

Responsibilities

• Perform quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined timeframes.
• 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.

Qualifications

• 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.

Compensation

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

Benefits

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

Equal Opportunity Employer

Integra LifeSciences 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.