Senior Auditor leading and executing internal audits at AAA Life. Ensuring compliance with internal policies and enhancing operational effectiveness.
About the role
- Lead Auditor overseeing corporate audits of Quality Management Systems in medical devices, driving compliance and improvement strategies across multiple facilities.
Responsibilities
- 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.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- savings plan (401(k))
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