Contact one of our consultants
Medical Device Lead Auditor (Active Devices) in UK
Title: Medical Device Lead Auditor - (Active Devices)
Location: Fully flexible across the UK. The role will involve frequent overnight stays so flexibility for this is essential. The role will be field based and therefore candidates must hold a full driving license.
Reporting To: Medical Device Auditor Team Leader
Direct Reports: No
Salary Range: £48,000 - £56,000 (Up to 10% annual bonus)
Travel Requirement: Yes – 75%
Benefits: Immediate Health Cover, 4-8% Pension, Company Car (allowance not available)
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.