IVDR Assessor/Auditor at DNV

, , Denmark -

Full Time

Start Date

Immediate

Expiry Date

22 Dec, 25

Salary

0.0

Posted On

23 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

In-Vitro Diagnostics, ISO 13485, IVDR 2017/746, MDSAP, Technical File Review, Quality Management System, Auditing, Customer Communication, Project Management, Certification Decisions, Surveillance Audits, Service Delivery, Efficiency, Accreditation, Documentation, Process Improvement

Industry

Public Safety

Description

As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments 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: Assessor Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete specific 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 decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Conduct Technical File reviews specific for products being authorized. Key Accountabilities: Auditor 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.

Responsibilities

The successful candidates will be responsible for planning and conducting audits and assessments of medical device manufacturing in accordance with relevant standards. They will also conduct Technical File reviews and manage auditing teams to ensure compliance and customer satisfaction.