IVDR Lead Auditor at DNV

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

10 May, 26

Salary

0.0

Posted On

09 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Auditing, ISO 13485, IVDR 2017/746, MDSAP, Quality Management System, Surveillance Audits, Customer Satisfaction, Project Management, Certification Recommendations, Technical Expertise, Risk Management, Regulatory Compliance, Service Delivery, Supplier Management, Documentation, Client Relationships

Industry

Public Safety

Description

Responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards. Key Accountabilities: Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits. Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. About Life Sciences We help our customers in medical devices, healthcare, and aquaculture/ocean industries build trust and transparency across their products, assets, and supply chains. By working with customers to certify medical technologies, support safe and sustainable healthcare practices, and advance responsible aquaculture and ocean stewardship, we help manage risks, meet regulatory demands, and achieve long-term goals. Drawing on deep technical expertise, we partner with customers worldwide to bridge trust gaps between patients, providers, producers, and consumers—driving sustainable results and improved ESG performance.

Responsibilities

The IVDR Lead Auditor is responsible for planning and conducting audits of medical device manufacturing in accordance with relevant standards. This includes managing auditing teams and ensuring compliance with quality management systems.