Lead Auditor

5 days ago

Sydney, New South Wales, Australia Dnv Germany Holding Gmbh Full time
About the Role

We are seeking a highly skilled Lead Auditor to join our team at DNV Germany Holding GmbH. As a Lead Auditor, you will be responsible for conducting audits and assessments of medical device manufacturers to ensure compliance with regulatory requirements.

Key Responsibilities
  • Conduct on-site audits and assessments of medical device manufacturers to ensure compliance with regulatory requirements
  • Develop and implement audit plans and procedures to ensure effective and efficient audits
  • Lead and manage audit teams to ensure high-quality deliverables
  • Provide expert advice and guidance to customers on regulatory requirements and industry best practices
  • Develop and maintain relationships with customers and stakeholders to ensure effective communication and collaboration
Requirements
  • Qualified as EU MDR Lead Auditor in a Notified Body
  • Minimum 4 years of experience in the medical devices industry, with a minimum of 2 years in quality management
  • ISO 13485 Audit Experience (3rd party Audit) for Active medical devices
  • ISO 13485 Lead Auditor Certification
  • Working knowledge of ISO 14971, medical device risk management
  • Ability to work independently and in teams, with excellent communication and interpersonal skills
What We Offer
  • Flexible work arrangements for better work-life balance
  • Guaranteed Superannuation
  • Generous Paid Leaves (Annual Leave, Compassionate Leave, Parental Leave)
  • Medical benefits
  • Pension and Insurance Policies (Group Life Insurance, Salary Continuance Insurance, Worker's Compensation for all employees, Corporate Business Travel Insurance)
About Us

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.

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