Quality Assurance Engineer

  • Groningen
  • 4500.00 - 6000.00
  • 32-40 hours
  • Master degree

Client

Our client is a leading project management and engineering company for industry around the world.

Client

Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence. They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.

Requirements

  • A relevant Bachelor or Master of Science degree (technical, life science or related).
  • Good working knowledge of the applicable regulations regarding the development and production of medical devices, in line with the Medical Devices Regulation, 21CFR Part 820, ISO 13485 and ISO 14971.
  • At least 5 years of relevant work experience preferably in the pharmaceutical or medical device industry.
  • Preferably working knowledge of validation of Automated / Computerized Systems and its validation.
  • Working knowledge of equipment qualification, process validation, risk management, change control.
  • Good communicative skills, excellent command of the English language and preferably the Dutch language.

What do you get?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Duties

  • Lead risk management activities (FMEA).
  • Support process validation process (IQ/OQ/PQ/Test Method Validation) via proactive support, and review and approval of documentation.
  • Support commercial manufacturing readiness.
  • Review and approve project documentation.
  • Ensure that the change control procedures are correctly applied.
  • Oversee QMS activities per existing plan and support execution.

TAGCLOUD

qualityassurance
#GMP
#medicaldevice
#qaengineer
#pharma
#validation
Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (947)

More information?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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