Medical Device Assessors & Lead Auditors - Non-Active Device
Medical Device Assessors & Lead Auditors - Non-Active Device
Join to apply for the Medical Device Assessors & Lead Auditors - Non-Active Device role at DNV
Medical Device Assessors & Lead Auditors - Non-Active Device
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Join to apply for the Medical Device Assessors & Lead Auditors - Non-Active Device role at DNV
About Us
We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.
About Us
We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.
As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.
About SCPA
We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their
- term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.
About The Role
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
- 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
- based or on client’s 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.
What we offer
- 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
About You
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
As part of this work experience, risk management experience should be covered:
- Practical experience in conducting
- 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
D 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.
Role
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
- 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
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
- going basis.
Seniority level
Seniority level
Not Applicable
Employment type
Employment type
Full-time
Job function
Job function
Design, Art/Creative, and Information TechnologyIndustries
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#J-18808-Ljbffr- Informações detalhadas sobre a oferta de emprego
Empresa: DNV Localização: Lisboa
Lisboa, Lisboa, PortugalPublicado: 5. 6. 2025
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