The Role
Conduct ISO 13485, MDSAP, and MDR audits and assessments for medical device organizations. Plan and deliver assessments, gap analyses, training workshops, and consultancy projects while maintaining auditor qualifications and regulatory registrations. Ensure independent, ethical auditing and contribute to continuous improvement in audit processes and service delivery. The role requires a relevant medical science or engineering degree, at least four years of hands-on medical device experience, strong communication skills, customer focus, teamwork, continuous learning, and English fluency.
Summary Generated by Built In
- Conduct audits and assessments in accordance with ISO13485, MDSAP, MDR based on the directive, regulation, harmonized standards and other applicable regulatory requirement following DNV’s accredited certification program and procedure.
- Ensure independent and ethical of all auditing activities, upholding DNV’s values of integrity and impartiality.
- Contribute to continuous improvement efforts by identifying and driving enhancements in audit processes, information management, and service delivery across teams.
- Plan and deliver client projects such as assessments, gap analyses, training workshops, and other consultancy activities as assigned.
- Maintain qualification and registration as a Lead Auditor/Assessor with DNV and relevant regulatory authorities.
- Perform additional duties as assigned by the line manager to support team and business objectives.
- Flexible work arrangements for better work-life balance
- Generous Paid Leaves (Annual Paid Leave, Sick Leave)
- Medical benefits (Standard medical check-up)
- Pension and Insurance Policies
- Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
- Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Professional Membership Fees)
*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.
- Relevant Bachelor or higher degree related to medical science and medical device area. Core disciplines: biology or microbiology; biomechanical engineering; chemistry or biochemistry, medicine and clinic practice; computer and software technology; electrical, electronic, mechanical or bioengineering. etc.
- Minimum 4 years of hands-on experience in the design, manufacturing, testing, or clinical use of medical devices within industry, laboratory, or hospital environments. Prefer product group: MDN1206 non-active ophthalmologic device, MDN1201 non-active deice for anesthesia, emergency and intensive care, MDN1202 non-active device for administration, channelling and removal od substances, including dialysis.
- High customer focus and service orientation
- Strong communication and interpersonal skills
- Proven ability to work collaboratively in teams and across functions
- Self-motivated with strong commitment to continuous learning and development
- Fluency in both written and spoken English is required
Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.
Skills Required
- Bachelor's degree or higher in a relevant medical science or medical device discipline, such as biology, microbiology, biomechanical engineering, chemistry, biochemistry, medicine, clinical practice, computer/software technology, electrical engineering, electronic engineering, mechanical engineering, or bioengineering.
- At least 4 years of hands-on experience in medical device design, manufacturing, testing, or clinical use within industry, laboratory, or hospital environments.
- Experience with relevant medical device product groups, preferably non-active ophthalmologic devices, anesthesia/emergency/intensive-care devices, or substance administration, channeling, and removal devices including dialysis.
- High customer focus and service orientation.
- Strong communication and interpersonal skills.
- Ability to work collaboratively across teams and functions.
- Self-motivated with a strong commitment to continuous learning and development.
- Fluency in written and spoken English.
- Ability to maintain qualification and registration as a Lead Auditor/Assessor with DNV and relevant regulatory authorities.
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The Company
What We Do
DNV is the independent expert in risk management and assurance, operating in more than 100 countries. Through its broad experience and deep expertise DNV advances safety and sustainable performance, sets industry benchmarks, and inspires and invents solutions.
