Quality Engineer Product (temporary contract for 8 months)

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Job description

Fujirebio Europe is looking to temporary strengthen its Quality & Compliance department at the European Headquarters in Ghent with a Quality Engineer Product position (Temporary contract for 8 months).

Ensure that in-vitro diagnostic test kits are developed & maintained during the whole product life cycle to meet customer expectations & in compliance with current quality & regulatory requirements.

Ensure customer satisfaction by providing appropriate solutions to customer complaints in a timely manner as part of an outstanding post-sales service.

 

Accountabilities

  • You review and approve technical documentation generated during the development process & improvement projects to ensure compliance towards applicable procedures.
  • You participate to design review meetings & act as quality expert in project teams.
  • You own and maintain the product risk management file from launch of the products.
  • You write and/or approve changes & CAPA’s.
  • You handle and follow-up product complaints from end users, affiliates, distributors and partners and provide timely and appropriate solutions.
  • You discuss complaints which could have consequences on public health and liaise with the Risk Assessment Committee in case of potential Reportable Events.
  • You provide support to the QC department (troubleshooting, training, expertise, …).
  • You optimise, validate and implement QC methods and procedures (QC, FQC, Stability, Sampling) in order to guarantee product quality until end of shelf life.

  
Profile

  • Master degree in bio-environment (pharmacy, biology, biotechnology) or equivalent by experience
  • 3 years quality experience in pharmaceutical or diagnostic environment
  • Insight in customer & market requirements
  • Positive, pro-active and flexible attitude
  • Experience in CAPA is a plus
  • Team player: open minded, cooperative, takes initiative
  • Good problem solving – problem analysis
  • Project management experience
  • Good written and oral communication skills
  • Languages: Dutch & English – good knowledge written & spoken

 
Contact

We welcome your application and the possibility to evaluate your curriculum!
Vicky Christiaens
Talent & Reward Manager
Technologiepark 6
B-9052 Zwijnaarde
Belgium
Tel: 09/ 329 16 26

 

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