Medical Device Auditor
2 weeks ago
We are seeking a highly skilled Medical Device Auditor to join our team at Det Norske Veritas. As a Medical Device Auditor, you will be responsible for conducting third-party onsite audits of medical devices and ensuring compliance with ISO 13485 and EU MDR requirements.
Key Responsibilities:- Conduct third-party onsite audits of medical devices to ensure compliance with ISO 13485 and EU MDR requirements.
- Perform technical documentation assessments based on EU MDR requirements.
- Schedule and plan audit activities with customers.
- Interact directly with customers at all levels of management to develop timely, complete, and accurate reports of their current level of compliance or implementation of their management system.
- Document and report audit and assessment activities and results.
- Provide timely and accurate reviews of customer corrective action and closure.
- Maintain appropriate audit credentials and pursue advancement of those credentials and other related credentials as needed.
- Bachelor's or Master's Degree in Biomedical Engineering, Electrical, Electronic, Mechanical engineering, Bioengineering; Medical technology, Materials science, Biotechnology, Chemistry, or other related fields relevant to Active or Non-active medical devices.
- Must be qualified as EU MDR Lead Auditor in a Notified Body.
- Minimum 4 years experience in the medical devices industry.
- Minimum 2 out of the 4 years must be within Quality Management.
- Must have ISO 13485 Audit Experience (3rd party Audit) for Active medical devices.
- Must have an ISO 13485 Lead Auditor Certification.
- Must have a working knowledge of ISO 14971, medical device risk management.
- Must have successfully completed training within ISO 13485:2016.
- Must have the ability to work independently and in teams.
- Proven project and/or team leader, delivering service excellence.
- Excellent interpersonal skills, including written and verbal in English, with excellent customer service skills.
- Ability to work in an international team, delivering and leading teams to produce high-quality deliverables on time and in budget.
- Ability to lead multiple projects in parallel, often with conflicting demands and timelines.
- Willingness to travel and work around Australia and other countries.
At Det Norske Veritas, we help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims, or optimizing and decarbonizing supply chains, we help companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results.
We are an equal opportunity employer and give 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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