Contact one of our consultants
Medical Device Lead Auditor in UK
Our client is a global leader in inspection, verification, testing and certification services and is recognized as the global benchmark in quality and integrity, being trusted all over the world. They have an excellent new opportunity for a Medical Device Lead Auditor to join their 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.
- 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 policies and accreditation/approval requirements.
- Project manage auditing teams, as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards.
Qualifications and experience
- Fully qualified Medical Device Lead Auditor working for a notified body, or as a Technical File Reviewer, or as a mixture of both.
- Strong background in the Medical Device industry and/or extensive experience working in a medical device related industry or activities including the relevant production technology. 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.
- Excellent working knowledge of ISO13485, MDD 93/42/EEC.
- Good manufacturing and technical knowledge of electro-medical devices (active devices); and their relevant harmonized standards.
- Experience of conducting MDSAP audits or standalone Technical File Reviews would also be advantageous.
- Must be able to demonstrate an excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
- Degree or higher in a relevant science / engineering subject or equivalent tertiary qualification for one or several technologies used in the medical device sector.
- Lower level tertiary qualifications supported by a minimum of 8 years’ experience in the technical field will also be considered.