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Medical Device Lead Auditor (Active Devices) in UK

Job Purpose:

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. 

Primary Responsibilities: 

  • 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.   

Reference

LM - MDLA

Location

UK
Must be fully flexible

Salary

£45,000-£60,000
£48,000 to £56,000

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