RQM  Salary

9 CRAIGEND CLOSE GLASGOW G13 2TZ

RQM
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RQM is looking for employees for positions:

quality manager

Responsibility

  • write/improve and train others on SOPs
  • perform gap assessments to prepare for external audits/FDA inspections
  • support external audits
  • coordinate and conduct internal audits
  • FDA inspection readiness and support
  • conduct EU MDR mock NB audits
  • develop/contribute to Quality System development: ISO 13485, QSR, MDSAP, 21 CFR 820, GMP
  • coordinate and conduct Supplier quality audits

Requirements

  • bachelor’s Degree in relevant subject
  • experience working within medical/diagnostic device in a quality role in industry
  • working knowledge of requirements such as 21 CFR 820, ISO 13485 and GMP
  • FDA Regulatory requirements, the EU Medical Device
  • experience with MDSAP audits
  • working knowledge of standards such as: ISO 13485:2016, EU MDR, GMP, safety risk management, 60601-1 3rd edition