Medical Device Lead Auditor

Job Type:
Industry Sector:
Consulting/Business Services Jobs
Industry Sub Sector:
£50, 000 - £59, 999
East Midlands, West Midlands
Executive Careers Ltd
Job Ref:

Medical Device Lead Auditor
Salary £45,000-£55,000


ISO 60601-1
ISO 14971:2012
ISO 13485
MDD 93/42/EEC

Main Purpose of Role
• To plan and conduct professional management system audits in accordance with procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards
• To assist in business development as required and to provide specific technical support to expand the Company’s capability to offer valued services to customers
• To carry out specific project tasks in relation to medical devices procedures, processes, systems and documentation

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 Files review specific for products being authorized for
• 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 medical devices operations manager
• Ensure completion of all assigned work and relevant documentation in accordance with required procedures and standards to fulfil customer expectations
• 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 and in line with policies and accreditation/approval requirements
• Manage personal schedule to work efficiently and to meet target chargeability requirements as defined by the Certification Manager
• 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
• Carry out internal audits of individual auditors, functions or offices to ensure internal compliance with relevant standards
• To manage personal expenditure required to fulfil the role in order that customer relations and profitability of the business are not compromised

Skills & Knowledge

• Must be able to demonstrate and excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques (Essential).
• Must be able to demonstrate a good knowledge of electro-medical devices (active devices); and/or sterilization and non-active devices
• Good experience with EN ISO 60601-1 3rd Edition and relative amendment; and/or Harmonised sterilization and cleanroom and on active medical device standards.
• Good experience with Risk Management EN ISO 14971:2012
• Good knowledge of ISO 13485, MDD 93/42/EEC and their application
• Good knowledge of Usability / Software

Contact Details:
Executive Careers Ltd
Tel: 01252 377177
Contact: Harvey Hills

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