Quality Engineering Manager: Drive Compliance & Impact

Integra LifeSciences; Plainsboro Township (NJ); On-site; USD 109,000 - 150,000; Full time

Job summary

Integra LifeSciences, located in Plainsboro, NJ, seeks a Manager of Quality Engineering to lead QA/QC support across manufacturing, product development, and risk management. This role ensures processes and products meet regulatory requirements and company standards.

You will guide nonconformances, CAPAs, and customer complaint investigations while mentoring a team of engineers to drive continuous improvement and robust technical decisions.

Qualifications

• BS degree in Engineering or Science is required.
• ASQ/CQE certification strongly preferred.
• 7–10 years of quality assurance engineering or manufacturing experience.
• Working knowledge of GMP, ISO 9001, ISO 13485, ISO 14971 is expected.
• Experience with regulatory submissions and audits is a plus.

Responsibilities

• Maintain understanding of applicable requirements and standards (FDA GMPs, ISO 9001, ISO 13485, ISO 14971).
• Lead Quality Engineering support across Manufacturing, QA/QC, Regulatory Compliance, and Product Development.
• Build and develop a high-performing team of quality engineers through mentoring and planning.
• Participate in new processes, transfers, CI activities, and issue resolution.
• Provide guidance on validation plans, test methods, sampling, and sterilization validation.
• Lead or support investigations of product, process, and equipment issues with root-cause analysis.
• Ensure deliverables are accurate, well-documented, and timely.

Skills

Communication skills

GMP knowledge

Quality engineering

Strategic thinking

Team leadership

Education

BS degree in Engineering or Science

ASQ/CQE certification

Tools

Microsoft Office

Job description

Integra LifeSciences, located in Plainsboro, NJ, seeks a Manager of Quality Engineering to lead QA/QC support across manufacturing, product development, and risk management. This role ensures processes and products meet regulatory requirements and company standards.

You will guide nonconformances, CAPAs, and customer complaint investigations while mentoring a team of engineers to drive continuous improvement and robust technical decisions.