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))

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

corporate auditsQuality Management System (QMS)GMPGDPGLPGCPISO 1348521 CFR Part 820process validationcomputer systems validation

Soft Skills

leadershipcollaborationcommunicationproblem-solvingconsultancyorganizational skillsinspection readinessteam coordinationreport writinganalytical skills

Certifications

Bachelor’s degreeMaster’s degreeFormal Auditor certificationIRCAASQ CQABSIExemplar Global