Hybrid ISO 13485 Lead Auditor

Posted 4 weeks ago

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About the role

  • Responsible for project management, audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report.
  • Providing the clients with 80% auditor (hats on) and 20% mentor (hats off).
  • Identifying and supporting the development of training modules required by the Audit Practice.
  • Maintaining their training in new / revised regulations, standards and guidance's as they become available.
  • This is a client facing role and the ideal candidate must have the quiet authority and confidence to arrange and host client meetings and conduct the audits.
  • As an auditor there will be challenging situations and difficult conversation with the client. The candidate must have the strength of character to manage these situations with tact, diplomacy and integrity. Admit when they are wrong and maintain their position when they are right.

Requirements

  • A professional and qualified Medical Device ISO 13485 Lead Auditor with extensive auditing experience in the Medical Device industry
  • Must have MDSAP auditing experience
  • FDA 21 CFR Part 820 experience
  • Must be fluent in English
  • Robust auditing experience

Benefits

  • Industry leading compensation package
  • Ongoing learning and development
  • Work life balance

Job title

ISO 13485 Lead Auditor

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Professional Certificate

Location requirements

HybridIndia

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