Medical Device Assessors & Lead Auditors - Non-Active Device

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.

As part of our continued growth we are looking to recruit technical and experienced Non-Active Medical Device Assessors and Lead Auditors throughout Europe. The successful candidates 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
Conduct assessments (either desk-based or on clients sites) in accordance with established procedures maintaining a high standard of service delivery that ensures effective customer relationships.
Conduct Technical File reviews specific for products being authorized.
Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
Complete specific projects in relation to medical device procedures processes systems and documentation as requested by the Medical Devices Operations Manager.
If required undertake reviews of packs and make certification decisions 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.

Please note that for candidates with employment history in Germany we cannot proceed to the interview stage without the following documents: Curriculum Vitae (CV); Cover- /Motivation Letter; University Diplomas & Transcripts; Reference Letter(s). All documents shall preferably be submitted in English. Please provide them at your earliest convenience to ensure a smooth and timely assessment cooperation in this matter is greatly appreciated.

A competitive compensation and benefit package
DNV training and qualification program
A professional community in a prestigious technological company
Possibilities to work with interesting and challenging projects
Access to an extensive competence network

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.

Position Qualifications:
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 preclinical 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 youll 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 youre interested in applying please submit your CV 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.