ISO13485 & MDR Auditor/Assessor (Taipei/Kaohsiung)

About the role

DNV is seeking an experienced auditor/assessor to conduct ISO13485, MDSAP and MDR audits for medical device clients in Taiwan. You will ensure independent, ethical audit execution while supporting continuous improvement of audit processes and service delivery.

Key responsibilities

• Plan and perform audits and assessments in line with ISO13485, MDSAP, MDR and related regulatory requirements.
• Uphold DNV’s values of integrity and impartiality throughout all auditing activities.
• Identify improvement opportunities and drive enhancements in audit processes, information management and service delivery.
• Deliver client projects such as gap analyses, training workshops and other consultancy activities.
• Maintain Lead Auditor/Assessor qualification and registration with DNV and relevant authorities.
• Support team and business objectives through additional duties assigned by the line manager.

Required profile

• Bachelor’s degree or higher in a medical‑science or medical‑device related field (e.g., biology, microbiology, biomechanical engineering, chemistry, biochemistry, medicine, computer/software technology, electrical, electronic, mechanical or bio‑engineering).
• Minimum 4 years of hands‑on experience in design, manufacturing, testing or clinical use of medical devices in industry, laboratory or hospital settings.
• Experience with non‑active device product groups such as ophthalmologic devices, anesthesia and intensive‑care devices, and devices for administration, channeling and removal of substances (including dialysis).
• Strong customer focus, service orientation and effective communication skills.

Required skills

• In‑depth knowledge of ISO13485, MDSAP and MDR regulatory frameworks.
• Auditing and assessment methodology for medical devices.
• Gap analysis and regulatory compliance expertise.
• Ability to deliver training workshops and consultancy services.

What we offer

• Flexible work arrangements to support work‑life balance.
• Generous paid leave (annual and sick leave) and standard medical check‑up.
• Pension and insurance policies.
• Training and development assistance, including sponsorship and on‑the‑job training.
• Additional benefits such as long‑service awards, mobile‑phone reimbursement and professional‑membership fee coverage.