Role: Medical Device Auditor
Salary: Negotiable dependant on experience
- Conduct audits (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 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 the companies policies and accreditation/approval requirements.
- Project manage auditing teams, as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards.
- 4 years of professional experience in relevant field of healthcare products or related activities e.g.:
- Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs
- 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 with the relevant national or international standards
- Conducting performance testing, evaluation studies or clinical trials of devices
- 2 years of the 4 of relevant professional experience shall be in quality management. E.g. Quality Manager/Engineer, CAPA or complaint Manager/Engineer.
- An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
- Good knowledge of ISO 13485, MDD 93/42/EEC and their application
- Knowledge of MDR 2017/745, MDSAP
- Work experience in positions with significant QA, Regulatory or management systems responsibility
- Experience with Harmonised medical device standards and for active & non active devices.
- Experience with Risk Management EN ISO 14971
- Medical device experience from auditing/work
- Experience auditing against recognised standards
- Experience of working under own initiative and in planning and prioritising workloads
- Solid knowledge of active and non-active devices
- GCSE Mathematics & English Language (or equivalent)
- University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology, Human Physiology, Nursing, Quality Management.
- Full driving licence for use in the UK