Lead Auditor, Quality Compliance

Role Overview

• Lead, coordinate and perform corporate audits of the Quality Management System (QMS) as part of Integra LifeScience’s quality internal audit program.
• Ensure that the corporate audit policy/procedures are fully implemented on audits conducted.
• Work alone or lead a multi-skilled team of auditors.
• Perform audits in compliance with recognized ISO, GMP, GDP, GCP, and GLP policies/procedures.
• Physically perform and be responsible for the audits assigned as part of the annual corporate audit schedule.
• Provide internal consultancy on specific area of expertise to the audit team and assist with improving audit standards and inspection readiness.
• Supply formal reports to the head of the audit program on site audits, including audit observations and recommendations.
• Identify problematic areas of site and quality system operations during audits and assist with improvement.

Requirements

• Experience with Corporate, divisional, site, supplier GMP, GDP, GLP or GCP audits as a Lead Auditor for multi-national manufacturing companies in the medical devices or pharmaceutical sector.
• Related quality/operations GMP work experience in a medical device or pharmaceutical manufacturing site or equivalent combination of education and work experience in QS/QA/QC/OPS or a technical management and supervisory function.
• Experience auditing technical files for conformance with EU regulations for CE-marked medical devices.
• Experience working for regulatory agencies or Notified Bodies preferred.
• Experience in one or more of these specialized technical areas: sterilization, microbiology, manufacturing facility engineering and design, statistical analysis, process validation, regulatory compliance, clinical trials, computer systems validation, quality systems and/or data security.
• A working knowledge of different languages and a willingness to travel widely, including internationally, (up to 50%) would also be considered as assets.
• Conducting supplier/regulatory compliance audits at medical device and/or pharmaceutical companies with a demonstrated ability to identify and resolve complex quality and compliance issues.
• Intimate knowledge of the 21 CFR Part 820, ISO 13485, EU Medical Device Regulation, and MDSAP country requirements; personal experience in the roll-out and implementation of GMP, GDP, GCP, GLP, and ISO 14971 would be considered an asset.
• Participated in or personally led audits of materials suppliers, manufacturing sites, distribution centers, and/or laboratories as a Lead Auditor or site QA/RA representative.
• Bachelor’s degree in engineering, or sciences or relevant technical field required.
• Master’s degree preferred.
• Formal Auditor certification by a recognized body (e.g., IRCA, ASQ CQA, BSI, Exemplar Global).
• Minimum 15 years of experience in auditing in quality, manufacturing, or engineering, or equivalent education and years of experience.
• Experience in FDA controlled environment.
• Strong collaboration skills and experience working in a matrix environment.

Tech Stack

• Google Cloud Platform

Benefits

• medical
• dental
• vision
• life insurance
• short
• and long-term disability
• business accident insurance
• group legal insurance
• savings plan (401(k))