Medical Device Auditor

Local Unit & Position Description

We are hiring Medical Device Auditor who are willing to relocate to Australia.

• Perform 3rd party onsite ISO 13485 (Medical Device) and MDR-QMS Audit
• Schedule and plan audit activity with customers;
• Interact directly with customers at all levels of management in developing timely, complete and accurate reports of their current level of compliance or implementation of their management system;
• Document and report audit activities and results;
• Provide timely and accurate reviews of customer corrective action and closure;
• Maintains appropriate audit credentials and pursues advancement of those credentials and other related credentials as needed;

Position Qualifications

• Bachelor's or Master’s Degree in Biomedical Engineering, biomechanical engineering; medical technology medicine, physics or biophysics; computer and software technology; electrical, electronic, mechanical or bioengineering; medical technology or other related fields;
• 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 and must be qualified as MDR Auditor.
• Must have an ISO 13485 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 i.e. 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;

Company & Business Area Description

DNV is the independent expert in assurance and risk management, operating in more than 100 countries. Through our broad experience and deep expertise we advance safety and sustainable performance, set industry benchmarks, and inspire and invent solutions.

We are one of the world’s leading certification, assurance and risk management providers. Whether certifying a company’s management system or products, providing training, or assessing supply chains, and digital assets, we enable customers and stakeholders to make critical decisions with confidence. We are committed to support our customers to transition and realize their long-term strategic goals sustainably, and collectively contributing to the UN Sustainable Development Goals.

DNV Singapore ranks number one in the Professional Services category in Singapore’s Best Employers 2022 survey conducted by the research firm Statista, in partnership with The Straits Times.

Equal Opportunity Statement

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!