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Medical Device Lead Auditor in UK
Medical Device Lead Auditor
Location: UK, Field based – National (Company Car provided)
Permanent, 37.5 hours per week
We have an excellent new opportunity for a Medical Device Lead Auditor to join a 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. Job entails a high level of National travel.
- 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.
To be considered for this role, you will 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.
- Full driving licence for use in the UK
The following attributes would be desirable, but not essential;
- Experience of reviewing audit packs
- Review of technical documentation
- Registered IRCA lead auditor, or equivalent registration under other recognised body
*Benefits: 10% performance bonus, retail discount scheme, private health cover, contributory stakeholder pension scheme and life cover.