Senior Quality Compliance Lead Auditor - Medical Devices

Integra LifeSciences Corporation; Columbia (MD); On-site; USD 109,000 - 150,000; 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 in Columbia, MD is seeking a Lead Auditor, Quality Compliance to join the Corporate Audit team. The role leads and coordinates audits of the Quality Management System across multiple facilities, ensuring compliance with ISO, GMP, GDP, GCP, and GLP while improving audit standards and reporting.

The incumbent provides SME coaching, supports inspection readiness, and drives CAPA reviews to deliver audits on time and within budget, helping advance patient outcomes in a global

Qualifications

• Experience with corporate, divisional, site, supplier GMP, GDP, GLP or GCP audits as a Lead Auditor for multi-national manufacturing companies in medical devices or pharmaceuticals.
• Experience auditing regulatory compliance, quality systems and supplier audits.
• Formal Auditor certification by a recognized body (e.g., IRCA, ASQ CQA, BSI, Exemplar Global).
• Bachelor’s degree in engineering or sciences; Master’s preferred; strong collaboration and travel readiness.

Responsibilities

• Lead, coordinate and perform corporate audits of the Quality Management System across multiple facilities.
• Produce objective audit reports and executive summaries for senior management.
• Coach auditees and SMEs to improve audit readiness and CAPA effectiveness.
• Support site inspections and drive continuous improvements in quality processes.

Skills

GMP audits

GCP audits

ISO 13485

Lead Auditor

Regulatory compliance

FDA experience

Cross-functional collaboration

Travel willingness

Education

Bachelor’s degree in engineering or sciences

Master’s degree preferred

Auditor certification (IRCA/ASQ etc.)

Job description

Integra LifeSciences in Columbia, MD is seeking a Lead Auditor, Quality Compliance to join the Corporate Audit team. The role leads and coordinates audits of the Quality Management System across multiple facilities, ensuring compliance with ISO, GMP, GDP, GCP, and GLP while improving audit standards and reporting.

The incumbent provides SME coaching, supports inspection readiness, and drives CAPA reviews to deliver audits on time and within budget, helping advance patient outcomes in a global