Medical Device Assessors & Lead Auditors - Non-Active (multiple locations)

Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below.

Non-Active devices

• Biology or Microbiology
• Biomechanical Engineering
• Chemistry or Biochemistry
• Dentistry
• Human Physiology
• Materials or Biomaterials Science
• Medical Technology
• Medicine, Veterinary Medicine
• Nursing
• Pharmacy, Pharmacology, Toxicology
• Physics or Biophysics
• Physiology

In addition to a relevant educational degree, candidates 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:

• Practical experience in conducting pre-clinical testing or assessing pre-clinical data with medical devices in one or more of the following areas such as biological safety, physical, chemical and microbiological characterization, stability, shelf life, performance and safety

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:

• Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) in a research and development, manufacturing, quality management or regulatory affairs capacity
• Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
• Work in the application of device technology and its use in health care services and with patients
• Testing devices for compliance in accordance to the relevant national or international standards
• Conducting performance testing, evaluation studies or clinical trials of devices

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

• An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
• Work experience in positions with significant QA Regulatory or management systems responsibility
• Experience with Harmonized medical device standards for active & non active medical devices
• Experience with Risk Management EN ISO 14971
• Experience with Sterilization techniques (such as ETO, Gamma, Steam, Dry Heat) and formal qualification desirable
• Medical device experience from auditing/work
• Experience auditing against recognized standards
• Experience of working under own initiative and in planning and prioritizing workloads
• Solid knowledge of medical devices
• Should have a flair for technical writing, essential for exhaustive report writing

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.

Successful candidate can be based in any EU country where DNV has an office. You will be hired on local conditions.

Interviews will be held on an on-going basis.