Medical Device Assessor / Lead Auditor - Active

Local Unit & Position Description

As part of our continued growth, we are looking to recruit a technical and experienced Active Medical Device Assessor / Lead Auditor in Europe. The successful candidate will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, MDR 745/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

Key Accountabilities:

Position Qualifications

Assessor / Auditor shall have a technical college degree in a relevant product or medical area, as described below.

Active devices

In addition to a relevant educational degree, the candidate must have a minimum 4 years’ work experience (full time) in a medical device related industry, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit / Assess, and/or experience as an assessor in a notified body (full five technical documentation assessments).

As part of this work experience, risk management experience should be covered:

A PhD in a relevant area for medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing.

To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:

In addition to the above you’ll also need to demonstrate the following;

If you're interested in applying, please submit your CV and cover letter in English.

Kindly be informed you may be requested to provide DNV with additional documents for a background check.

You will be hired on local conditions.

Interviews will be held on an on-going basis.

Company & Business Area Description

DNV is a global leader and innovator in inspection, verification, testing and certification services. Founded in 1864, DNV is recognized as the global benchmark in quality and integrity. We encourage new ideas, we welcome people who challenge the way we do things, and we will be 100% committed to helping you reach your full potential.

DNV Product Assurance AS is an accredited Certification Body and MDR approved Notified Body for Medical Devices and Hazardous Area Equipment. We provide global market access by testing and certifying the safety and quality of products and systems to international safety and quality standards and regulations. Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organisation that invests in its employees, and is committed to providing you with continued development. 

Equal Opportunity Statement

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!