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Lead Auditor - ISO 13485 in UK
Purpose of the role:
The successful candidate will be responsible for planning and conducting professional management system audits in accordance with the company’s procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
- Conduct audits (desk-based or on client’s sites) in accordance with Medical Devices management systems standards ISO 13485.
- Maintain a high standard of service delivery completing all chargeable work within the required budget and timeframes.
- Provide accurate and timely reporting to assist the planning and management of operations.
- Support business development activities as required (including follow up and/or referral of enquiries, sales visits, assistance at events, seminars, etc)
- 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.
Qualifications and skills:
- Knowledge thorough post-secondary education or equivalent work experience in one or several of the following areas: electronic, electrical, mechanical and software technology Medical devices.
- Good technical, design and manufacturing knowledge of electro-medical devices, the technology involved and their intended uses.
- 4 years’ experience or more working in the medical device related industry or activities.
- Excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques and auditing against recognised standards
- Excellent working knowledge of ISO 13485 and its application.
- Work experience in positions with significant QA, Regulatory or management systems responsibility.
- Knowledge of Risk Management EN ISO 14971:2012.
- Able demonstrate good manufacturing and their relevant harmonized standards.
- Able to demonstrate ability to identify and capitalise on any potential to maximise sales/revenue generated by the business.
- Knowledge of Legal Framework of regulations and role of the Certification Body.
- Experience of Electromechnical Medical Device (including IVD), IT Software or Engineering Services within the Medical Device Manufacture Industry.
- Experience with Harmonised sterilization, clean-room and non-active medical device standards.
- Experience in the operation of the relevant sterilization processes.
- Knowledge of MDD 93/42/EEC and their application.