Quality Systems Engineer

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What you need to know

I’m looking to speak to Quality Systems Engineers who are experienced in working in high volume production facilities and who are interested in pursuing new opportunities in the Midlands areas. This is a permanent job and a great opportunity to work for a reputable and successful Medical Device organisation.

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In this role you will have responsibility of providing Quality systems support in relation to all QMS processes, to ensure compliance to quality standards, policies, procedures and FDA regulations. The successful candidate will be strong with documentation management, possess excellent communication and presentations skills, along with the ability to present an independent opinion.

Key duties & responsibilities:

  • Document Control
    • Create, maintain and manage Controlled Document Stations
    • Organise the distribution of specifications to suppliers
    • Ensure all documents in all media variants are compliant
  • Change Control
    • Manage change control system and train staff on change order process
    • Assist staff with change orders, risk assessments and validation requirements
    • Track and manage change orders and related metrics
  • Internal Audits
    • Review and approve results of internal audits
    • Prepare metrics and coordinate internal review meetings
    • Work with the Quality Systems Manager to prepare and execute the audit schedule

What are we looking for?

  • Minimum of level 8 Degree in Engineering, Science or related subject is essential
  • A minimum of 5 years industry experience. Medical device experience strongly preferred.
  • Familiarity with ISO quality systems (ISO9001, ISO14001 and/or ISO13485)
  • Experience in working in High Volume Production Facility
  • Strong computer and document management skills

Apply for this job now or get in touch with Gareth on 090 6490485.

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Recruitment Consultant: Gareth Morris

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