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.
About The Role
- Conduct third-party onsite ISO 13485 (Medical Device) and MDR-QMS audits.
- Perform Technical Documentation Assessments based on EU MDR requirements.
- Schedule and coordinate audit activities with customers.
- Engage directly with customers at all management levels to develop comprehensive, accurate reports on their compliance status or management system implementation.
- Document and report on audit and assessment activities and outcomes.
- Review customer corrective actions and closures promptly and accurately.
- Maintain appropriate audit credentials and actively pursue the advancement of these and other related credentials as needed.
- Identify and engage new customers for medical technology certification needs within the ASEAN market.
- Participate in events, trade shows, and conferences to promote DNV’s Medical Technology services.
About You
- 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, and or MDD, MDSAP auditors 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 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.
- Commercial acumen to support medical certification business growth.
