Contact one of our consultants
Medical Device Lead Auditor (Active Devices) in UK
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.
- 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 specific projects in relation to medical device procedures, processes, systems and documentation as requested by medical devices operations manager.
- Ensure completion of all assigned work and relevant documentation in accordance with required procedures and standards within the required budget and timeframes.
- Provide accurate and timely reporting as required by line management to assist the planning and management of operations.
- If required undertake reviews of packs and make certification decisions within target timescales in line with company policies and accreditation requirements.
- Project-manage auditing teams, as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards.
- Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant auditor registrations and relevant industry knowledge.
- If required, to provide technical support and staff training to all parts of the business in UK and overseas to enhance the service capability of the business.
- Support business development activities as required (including follow up and/or referral of enquiries, sales visits, assistance at events, seminars, etc) to enable on-going growth of the business.
Qualifications and Skills:
- Bachelor's degree in a relevant technology or equivalent tertiary qualification, for one or several technologies used in the medical device sector. Candidates with lower level tertiary qualifications supported by a minimum of 8 years’ experience in the technical field will also be considered.
- Applicants should have excellent working knowledge of ISO 13485, MDD 93/42/EEC, good manufacturing and technical knowledge of electro-medical devices (active devices) with ideally 4 years’ working experience in a medical device related industry.
- This must include:
- At least 2 years in a technical, quality or manufacturing role; the application of the device in health care services with patients; testing devices; performance testing, evaluation studies or clinical trials of devices and must be able to demonstrate an excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.