Lead Auditor, Quality Compliance

About the role

This position sits within the Corporate Audit team and is responsible for leading, coordinating, and carrying out corporate audits of the Quality Management System (QMS). The audits support Integra LifeSciences’ internal quality audit program across more than 15 design, manufacturing, and distribution sites, covering a broad portfolio of medical devices.

The company describes its mission as creating meaningful change in healthcare and values fresh thinking as a driver of opportunity and progress.

Key responsibilities

• Use evidence-based audit methods to verify that global QMS policies, standards, procedures, and all applicable regulatory and legislative obligations are being followed consistently and at the required standard.
• Prepare formal written audit reports for the head of the audit program, summarizing how the audit was performed, the setting in which it took place, categorized observations and recommendations, the overall site rating, and an executive summary suitable for senior quality, supply chain, regulatory, product development, and business leaders.
• Spot weak points in site and quality system operations during audits and help site teams with guidance, suggestions, and follow-up support to close gaps and improve performance.
• Contribute to inspection readiness through corporate audits, high-risk CAPA reviews, mock inspection exercises, and coaching for subject matter experts and auditees.
• Work with the head of the audit program to improve the efficiency and effectiveness of corporate audit processes and systems while maintaining strong quality control.
• Help drive consistent global implementation of policies at divisional, site, and third-party levels through auditing, education, communication, and enforcement.
• Lead or directly take part in the required number of corporate audits and partner with site quality representatives to complete reports within standard timelines.
• Recommend additional actions for audited sites where needed, including follow-up audits or re-audits, and support continuous improvement or quality initiatives as a representative of the global quality organization.
• Provide technical review and support to individuals, working groups, sites within the company, and approved external suppliers in the relevant area of expertise.
• Continue building personal technical, professional, and audit expertise while staying within the scope of the role.
• Promote a strong quality culture focused on continuous improvement and cross-functional collaboration.
• Act as a technical leader and coach for team members across functions and geographies.
• Carry out other related duties as required.

Experience and qualification requirements

• Background as a lead auditor conducting corporate, divisional, site, supplier, GMP, GDP, GLP, or GCP audits in multinational medical device or pharmaceutical companies.
• Relevant quality, operations, GMP, QA, QC, or supervisory/manufacturing experience in a medical device or pharmaceutical environment, or a comparable mix of education and work experience.
• Experience auditing technical files for compliance with EU requirements for CE-marked medical devices.
• Exposure to regulatory agencies or notified bodies such as FDA, MHRA, TGA, Health Canada, SFDA, ANVISA, BSI, NSAI, LRQA, or TüV is preferred.
• Practical knowledge in one or more specialist areas such as sterilization, microbiology, facility engineering and design, statistical analysis, process validation, regulatory compliance, clinical trials, CSV, quality systems, or data security.
• Ability to work with multiple languages and willingness to travel extensively, including internationally, up to 50%.
• Experience performing supplier or regulatory compliance audits in medical device and/or pharmaceutical settings, with proven ability to resolve complex quality and compliance issues.
• Strong working knowledge of 21 CFR Part 820, ISO 13485, EU Medical Device Regulation, and MDSAP country requirements; experience implementing GMP, GDP, GCP, GLP, and ISO 14971 is an advantage.
• Direct participation in or leadership of audits across material suppliers, manufacturing facilities, distribution centers, and/or laboratories.
• Bachelor’s degree in engineering, sciences, or another relevant technical field is required; a master’s degree is preferred.
• Formal auditor certification from a recognized organization such as IRCA, ASQ CQA, BSI, or Exemplar Global.
• At least 15 years of experience in auditing, quality, manufacturing, or engineering, or an equivalent combination of education and experience.
• Experience in an FDA-regulated environment.
• Strong collaboration ability and comfort working in a matrixed organization.

Additional information

Integra LifeSciences states that it does not accept unsolicited help from search firms for this role. Any CVs or resumes submitted by agencies without a valid written agreement for this position will be treated as company property, and no fee will be paid if a candidate is hired through an unauthorized referral. A formal written agreement must be in place and authorized by the Vice President, Talent Acquisition before any agency engagement. Agency introductions are position-specific and may only happen within the scope of an approved agreement. The company also asks that no phone calls or emails be made regarding this opportunity.

About the employer

Integra LifeSciences operates across a global healthcare environment and works on medical devices that support improved patient outcomes. The organization emphasizes innovation, collaboration, and continuous improvement.