Job Description

We have an excellent new opportunity for a Medical Device Lead Auditor to join our global organisation. The successful candidate will be responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

Key Accountabilities

• 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 SGS policies and accreditation/approval requirements.
• Project manage auditing teams, as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards.

Qualifications

To be considered for this role, you’ll require a minimum of 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.

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
• 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

Required Knowledge, Skills, and Abilities