Quality Manager - Medical Devices

Solothurn  ‐ Onsite
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Description

On behalf of our client, an international company specialized in medical devices, we are looking for a Sterility Assurance Specialist with previous experience working in the medical devices sector.

Main tasks in the remediation project:
  • Create, review, correct and release any documents to cover the reprocessing program (e.g. Cleaning Program, Steam Sterilization Program).
  • Support and ensure sterility validations (e.g. cleaning validation, steam sterilization validation) are remediated and following the current standards.
  • Train PD, consultant and other personnel in basic cleaning, disinfection and sterilization procedures.
  • Review external validation protocols and reports to ensure Synthes and regulatory requirements are met.
  • Create internal validation protocols and reports.
  • Ensure that all validations are in compliance with the current clinical reprocessing information given to the customers
  • Other duties/responsibilities as assigned by manager.


Requirements:
  • Knowledge Medical Device Directive (MDD), ISO13485, ISO 14971 and FDA (QSR) regulations.
  • Well known with critical design features for clinical reprocessing
  • Experience in ETO validation is an advantage
  • This position requires a high level of written and oral communication skills and the ability to interact with managers at all levels as well as personnel at the operating unit level
  • English fluent


If this attractive opportunity sounds interesting to you or for more information on this or other opportunities, please do not hesitate to contact Ms Burcu Parilti at Real Staffing on or
Start date
08/2015
Duration
12 month
From
Real Staffing
Published at
29.07.2015
Project ID:
955026
Contract type
Freelance
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