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 eg:
Work in medical devices industry or closely related industries (eg 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. eg 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.