Medical Device Lead Auditor in UK

Medical Device Lead Auditor

Location: UK, Field based – National (Company Car provided) 

Permanent, 37.5 hours per week

Job Description

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. 

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 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.