About SCPA
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, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.
Responsibilities:
Perform 3rd party onsite ISO 13485 (Medical Device) and MDR-QMS Audit.
Perform "Technical Documentation Assessment" based on EU MDR requirements.
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 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.
Benefits:
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).
Profit Share.
*Benefits may vary based on position, tenure/contract/grade level*
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.
Minimum Requirements:
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 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.
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