Medical Device Assessors

2 weeks ago

Sverige, Sweden DNV Germany Holding GmbH Full time

AboutSCPA

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 long-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.

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.

Successful candidate can be based in any EU country where DNV has an office.

Responsibilities:
  • 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 relationships.
  • Conduct Technical File reviews specific for products being authorized.
  • Complete all chargeable work within the required budget and time frames 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.

• Colleagues with high technical and regulatory skills.
• Work environment with high focus on well-being and high standards for personal and professional development.
• Challenging and attractive position with professional development through work and training.

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.

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

Active devices

  • Computer and Software Technology
  • Electrical, Electronic, Mechanical or Bioengineering
  • Medical Technology

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:

  • 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
  • Programming (Software) experience would be beneficial

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.

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