Medical Device Auditor Leader

3 semanas atrás


Campinas, São Paulo, Brasil Bureau Veritas Group Tempo inteiro
About Us

Bureau Veritas Group is a leading certification company and testing laboratory, dedicated to providing certification and conformity evaluation services worldwide.

Job Description

We are seeking a highly skilled and experienced Leader Auditor to join our team. The successful candidate will be responsible for leading audit teams, preparing audit plans, and conducting audits in accordance with international standards.

Responsibilities

The Leader Auditor will be responsible for:

  • Managing audit teams and preparing audit plans
  • Conducting audits in accordance with international standards
  • Reviewing and submitting formal audit reports
  • Complying with deadlines established by the program and Bureau Veritas
Requirements

To be successful in this role, the candidate must have:

  • A diploma or degree from a university or technical college in medicine, science, or engineering
  • At least four years of full-time relevant experience in one or more of the following areas:
    • Design and development, production, manufacturing, and quality control of medical devices
    • Study of medical device technology and its application
    • Conducting tests on medical devices in accordance with national or international standards
    • Performance testing, evaluation studies, or clinical trials of medical devices
  • 40 hours of lead auditor training in Quality Management System
  • 8 hours of training in ISO 13485
  • 32 hours of training in medical device regulations (MDSAP Audit Approach)
  • 8 hours of training in risk management, related to project and QMS
  • Statistical analysis
  • Product, process, or standards knowledge requirements
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional development and growth.



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