ISO13485 & MDR Auditor/Assessor – Taipei/Kaohsiung

About the role

DNV is seeking an experienced auditor to conduct ISO13485, MDSAP and MDR assessments for medical device clients in Taiwan. The role involves independent auditing, driving continuous improvement, and delivering client projects such as gap analyses and training workshops.

Key responsibilities

• Perform audits and assessments in line with ISO13485, MDSAP and MDR requirements.
• Uphold DNV’s values of integrity and impartiality throughout all auditing activities.
• Identify and implement enhancements to audit processes, information management and service delivery.
• Plan and deliver client projects including assessments, gap analyses, and training workshops.
• Maintain Lead Auditor/Assessor qualification with DNV and relevant regulatory authorities.
• Support team and business objectives with additional duties as assigned.

Required profile

• Bachelor’s degree or higher in a medical science, engineering or related field (e.g., biology, biomechanics, chemistry, medicine, computer/software technology, electrical/mechanical/bio‑engineering).
• Minimum 4 years of hands‑on experience in design, manufacturing, testing or clinical use of medical devices.
• Experience with non‑active ophthalmologic devices, anesthesia and intensive‑care devices, or administration/ dialysis devices is preferred.
• Strong customer focus, service orientation and effective communication skills.

Required skills

• ISO13485 auditing
• MDSAP auditing
• MDR regulatory knowledge
• Medical‑device auditing and assessment
• Lead Auditor/Assessor qualification

What we offer

• Flexible work arrangements for better work‑life balance
• Generous paid leave (annual and sick leave)
• Medical benefits including standard health check‑up
• Pension and insurance policies
• Training and development assistance (sponsorship, on‑the‑job training, programmes)
• Additional benefits such as long‑service awards, mobile‑phone reimbursement and professional‑membership fees