Vice President, Global Quality Systems & Compliance

Integra-Lifesciences; Princeton (NJ); On-site; USD 225,000 - 316,000; Full time

Job summary

Integra LifeSciences seeks a VP, Corporate Quality Systems to design and oversee the global quality system, ensuring compliant development, manufacturing and distribution of medical devices. The role partners with regulatory bodies and senior leadership, driving remediation, CAPA and continuous improvement across sites worldwide.

The candidate will lead a cross‑functional team, promote lean and Six Sigma methods, and ensure preparedness for FDA and international audits while traveling up to 50%

Qualifications

• Bachelor's degree in engineering, science or related technical field required; master’s preferred.
• Extensive leadership experience in highly regulated industries, medical device or pharma favored.
• Knowledge of FDA regulations, ISO 13485, CMDR, MDR, MDSAP, JPAL, and IVD/import requirements.

Responsibilities

• Build a high-performance quality culture and team; empower reports and cross-functional stakeholders.
• Lead global quality system design, implementation, and remediation in collaboration with CMP teams.
• Ensure compliance with FDA Part 820, ISO 13485, CMDR, MDR, MDSAP, and JPAL across sites.

Skills

Regulatory compliance

Quality leadership

Cross-functional collaboration

Process design

Change management

Data analysis

Education

Bachelor's degree in engineering/science

Master’s degree preferred

Tools

QMS software

CAPA tooling

Job description

Integra LifeSciences seeks a VP, Corporate Quality Systems to design and oversee the global quality system, ensuring compliant development, manufacturing and distribution of medical devices. The role partners with regulatory bodies and senior leadership, driving remediation, CAPA and continuous improvement across sites worldwide.

The candidate will lead a cross‑functional team, promote lean and Six Sigma methods, and ensure preparedness for FDA and international audits while traveling up to 50%