Medical Device Quality Systems Specialist - Audits

Job Ref: J30605
Sector: Science
Sub-sector: Biotech/Life Sciences
Job Type: Permanent
Date Added: 27 February 2019
  • West Midlands, England, UK West Midlands West Midlands UK B15 1QT
  • £1 per Annum
    ANNUM
  • Oliver Sampson
  • 01865 784826
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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Quality Systems Specialist - Audits Are you experienced working with quality systems under ISO13485 and FDA regulations? Are you looking for the next move in your career where you will be able to influence the direction of a multinational biotechnology company that has shown continued growth over the past 5 years? My client is looking for a suitable qualified individual who has experience working on the quality system of medical device to join their QA team and are offering an attractive package. Job Purpose:To conduct internal and supplier audits as Lead Auditor to meet regulatory requirements and follow up to ensure any deficiencies are appropriately addressed i.e. NCRs and CAPAsKnowledge and SkillsEssential:Biological or chemical based degree or equivalent.Qualified Lead Auditor.Training in FDA Quality System Requirements.Full understanding of ISO13485 / FDA QSR.CAPA Management.Audit planning, execution and follow-up.Able to manage multiple projects.Good problem-solving skills and attention to detail.Excellent communication skills - both verbal and written.Desirable:Process and equipment validation training attendedJapanese Ordinance 69/ISO9001, Health Canada and CMDCAS requirements.Experience of research and development of biological and chemical based products.IVD DirectiveKnowledge of antibody/ antigen reactions.To discuss this role and the company informally please call Oliver on 0121 7288454

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

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29/03/2019 10:34:24
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