Quality Engineering Leader – Medical Devices

INTEGRA LIFESCIENCES CORP; Plainsboro Township (NJ); On-site; USD 109,000 - 150,000; Full time

Job summary

Integra LifeSciences seeks a Manager, Quality Engineering in Plainsboro, NJ to lead a team providing GMP‑compliant quality engineering support across manufacturing, development and validation projects. You will drive CAPAs, risk assessments, and investigations, mentor engineers, and partner with QA, Regulatory and Operations to ensure product quality, regulatory readiness and continuous improvement.

You will build a strong team, mentor engineers, and partner with QA, Regulatory and Operations to

Qualifications

• BS degree in Engineering or Science; ASQ/CQE preferred.
• 7–10 years in quality assurance/engineering in manufacturing.
• Strong written and verbal communication.
• Knowledge of FDA GMPs, ISO 9001/14971/13485; medical device exp preferred.
• Ability to think strategically and lead cross-functional teams.

Responsibilities

• Maintain understanding of applicable requirements and standards (FDA GMPs, ISO 9001, ISO 14971, ISO 13485, MDSAP).
• Lead Quality Engineering support for Manufacturing, QA/QC, Regulatory Compliance, Product Development, and other partners.
• Build and develop a strong team of quality engineers through hiring, onboarding, coaching, and resource planning.
• Develop and implement new processes, transfers, and continuous improvement activities.
• Provide guidance on verification/validation plans, process validation, test methods, and sterilization validation.
• Lead or support investigations involving product, process, equipment, and validation.
• Provide QA partnership for nonconformances and customer complaint investigations with RCA and CAPAs.
• Ensure deliverables are complete, accurate, and documented within timelines.
• Lead risk-management activities and analyze data to identify improvement opportunities.
• Participate in regulatory submissions, inspections, and audits.

Skills

Quality engineering

GMP knowledge

Regulatory knowledge

Leadership

Communication

Education

BS in Engineering or Science

ASQ/CQE certification

Tools

MS Office

Quality Management System

Job description

Integra LifeSciences seeks a Manager, Quality Engineering in Plainsboro, NJ to lead a team providing GMP‑compliant quality engineering support across manufacturing, development and validation projects. You will drive CAPAs, risk assessments, and investigations, mentor engineers, and partner with QA, Regulatory and Operations to ensure product quality, regulatory readiness and continuous improvement.

You will build a strong team, mentor engineers, and partner with QA, Regulatory and Operations to