ISO13485 Lead Auditor - Field based covering the North

  • Salary: circa £35-65,000 DOE
  • REF Number: 00042936
  • Consultant: Natalie Wood
  • Contact: 01246 457723
  • Date Published: 29.08.2018
  • Closed Date: 22.10.2018
  • Sector: Other, Medical Devices
  • Location: East Midlands, North And Mid Wales, North East, North West, Yorkshire, Home/Field Based, Humberside
  • Discipline: Qa/Validation, Other

We're looking for a medical devices experienced Lead Auditor! The ISO13485 Lead Auditor will be joining a contract testing company in their ISO13485 medical devices business unit. This is a full time, permanent role and this person can be field based covering the North.

The Company:

Our client is a global leader and innovator in inspection, verification, testing and certification services. Trusted all over the world, our client is a market leader because they put 100% passion, pride and innovation into everything they do.

A vacancy has arisen for an ISO13485 Lead Auditor to join the team within the business unit focusing on the manufacture of medical, precision and optical instruments, watches & clocks. This is a field based role, in which travel will be required 75% of the time - therefore candidates must hold a full driving license and be flexible regarding over night stays. This role reports into the Product Operations Manager.

The Role:

Your main duties will be:-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 that ensures effective customer relationships and ongoing business development.
  • Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
  • 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 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) to enable on-going growth of the business.
  • Manage personal schedule to work efficiently and to meet target chargeability requirements as defined by the Regional Manager.
  • Project-manage auditing teams, as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards.

Your Background:

The ideal candidate for this role will have:

  • Ideally a range of electro medical devices/ manufacturing experience, however general medical devices experience will be considered.
  • Experience or responsibility of an ISO 13485 system and excellent working knowledge of ISO 13485 and its application.
  • A range of awareness of electrical components within the medical device industry.
  • Work experience in positions with significant QA, Regulatory or management systems responsibility.
  • Knowledge of Risk Management EN ISO 14971:2012.
  • Able to demonstrate an excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
  • Good knowledge of Design, manufacturing of medical devices, the technology involved and their intended uses.
  • Will be able demonstrate good manufacturing and technical knowledge of electro-medical devices and their relevant harmonized standards.
  • Please note this role will be field based and therefore candidates must hold a full driving license.

The Benefits:

  • Field based role-Salary offered is dependant on experience up to £65,000pa - some training may be available (starting salary from training will be circa £35,000pa)
  • Bonus of up to 10%
  • Immediate Health Cover
  • Pension scheme
  • Company Car

For more information or to apply for this position, please contact Natalie Wood on 01246 457723 or email nwood@ckscience.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CH42936 in all correspondence.

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