Global VP, Quality Systems & Compliance

Integra LifeSciences Corporation; Princeton (NJ); Hybrid; USD 225,000 - 316,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) savings plan

Job summary

Integra LifeSciences Corporation seeks a Vice President, Corporate Quality Systems to design, implement and oversee the global quality system across Integra sites. You will lead cross-functional teams in manufacturing and distribution, drive compliance with FDA 820, ISO 13485, CMDR, MDR, and other standards, and partner with regulatory bodies as needed.

In this senior role you will develop governance, establish KPIs, manage CAPA, document control, training and audits, and foster a culture of

Qualifications

• Bachelor’s degree in engineering, science or closely related technical discipline; master’s degree preferred.
• 18+ years of leadership experience managing teams or projects.
• Experience in highly regulated industries, medical device/pharma preferred.
• Strong analytical, writing and interpersonal skills.
• Knowledge of FDA, ISO 13485, CMDR, MDR, MDSAP and JPAL is required.

Responsibilities

• Design, implement and evolve the Global Quality System across Integra sites.
• Lead cross-functional teams including manufacturing, product development, operations and regulatory affairs.
• Interact with regulatory bodies and manage responses to authorities.
• Develop governance, KPIs and remediation strategies; monitor remediation through QMS.
• Foster a culture of quality and continuous improvement using Lean/Six Sigma.

Skills

Leadership

Quality systems

Regulatory compliance

FDA regulations

Cross-functional

Process design

Education

Bachelor’s degree in engineering, science or closely related technical discipline

Master’s degree preferred

Tools

Document control

CAPA systems

Job description

Integra LifeSciences Corporation seeks a Vice President, Corporate Quality Systems to design, implement and oversee the global quality system across Integra sites. You will lead cross-functional teams in manufacturing and distribution, drive compliance with FDA 820, ISO 13485, CMDR, MDR, and other standards, and partner with regulatory bodies as needed.

In this senior role you will develop governance, establish KPIs, manage CAPA, document control, training and audits, and foster a culture of