Company: |
DNV |
Job Role: |
Medical Device Auditor. |
Experience: |
(4-5 years). |
Vacancy: |
65+ |
Qualification: |
Bachelors Degree in Engineering or related skills. |
Salary: |
AUD 99,300/year. |
Location: |
Australia, India. |
Join us on Telegram |
Click Here |
Apply Mode: |
(Online) |
Deadline: |
Not Mentioned |
About the Company:
DNV, which has operations in more than 100 countries, is the independent authority on risk management and assurance. DNV enhances safety and sustainable performance, establishes industry benchmarks, and inspires and creates solutions because to its extensive experience and in-depth expertise. DNV empowers its clients and their stakeholders to confidently make important decisions, whether it be evaluating a new ship design, enhancing the operation of a wind farm, analysing sensor data from a gas pipeline, or certifying a food company's supply chain. DNV is a trusted voice for many of the most prosperous and forward-thinking businesses in the world and helps address the issues and global transitions facing its customers and the world today because it is driven by its goal, which is to safeguard life, property, and the environment.
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!
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How to Apply
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