Quality Engineering Manager: Lead Validation & Process Improvement

Integra LifeSciences Corporation; Plainsboro Township, Northern (NJ, KY); Hybrid; USD 109,000 - 150,000; Full time

Job summary

Integra LifeSciences is seeking a Manager of Quality Engineering to lead QA/QC and manufacturing quality support. You will drive investigations, validation, risk management, and cross-functional collaboration to ensure compliant, high-quality products.

The role calls for strategic thinking, strong communication, and a track record of building capable teams to meet regulatory expectations across FDA GMPs and ISO standards.

Qualifications

• BS degree in Engineering or Science.
• 7–10 years of quality assurance engineering/manufacturing experience.
• Working knowledge of GMP, ISO 9001, ISO 14971, ISO 13485 and related standards.
• Excellent written and verbal communication skills.
• Ability to lead teams and collaborate跨 functions.

Responsibilities

• 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, testing methods, and revalidation.
• Lead technical investigations for product, process, equipment, validation, and manufacturing issues.
• Ensure deliverables are complete, well-documented, and on schedule.
• Support risk-management activities and regulatory submissions and audits.

Skills

Quality assurance

Manufacturing engineering

Validation

Risk management

GMP knowledge

Communication skills

Education

BS in Engineering or Science

ASQ/CQE certification

Tools

Microsoft Office

Job description

Integra LifeSciences is seeking a Manager of Quality Engineering to lead QA/QC and manufacturing quality support. You will drive investigations, validation, risk management, and cross-functional collaboration to ensure compliant, high-quality products.

The role calls for strategic thinking, strong communication, and a track record of building capable teams to meet regulatory expectations across FDA GMPs and ISO standards.