Supplier Quality Engineer

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Job description

To support our strategy we are strengthening is strengthening our quality & compliance team with a Supplier Quality Engineer position.

You carry the responsibility to build & manage a compliant supplier qualification program & to establish effective supplier relations to guarantee the product quality of goods & services delivered by supplier:

  • You implement and maintain supplier related procedures compliant with all applicable regulations,
  • You evaluate the suppliers’ ability to meet the quality requirements,
  • You negotiate with suppliers on supplier quality agreements,
  • You set up a supplier audit planning and you perform supplier audits
  • You act as spokesperson during internal and external audits in relation to supplier qualification procedures and activities.

You participate in development and improvement projects to ensure that supplied goods/services are compliant with the quality & regulatory requirements:

  • You approve quality requirements and related incoming quality control procedures following new product developments,
  • You review and approve raw material related protocols & reports supporting root cause analyses or changes, corrective and preventive actions related to product quality,
  • You maintain raw material related risk management files.

You support the QC department (troubleshooting, training, expertise, …) related to incoming raw materials.

 

Profile

  • Master in pharmacy, (bio)-engineering, (bio)-chemistry or biology
  • 3 years experience in a GxP environment, preferentially in quality assurance in pharmaceutical, biotechnology or medical device industry
  • Knowledge & understanding of worldwide quality standards and guidelines, e.g. ISO13485, CFR Part 820
  • Knowledge & understanding of worldwide design control related regulatory standards & regulations
  • Good communication and negotiation skills
  • Project management experience
  • Audit skills
  • Good written and oral communication skills
  • Fluent English/Dutch
  • Team player: open minded, cooperative, takes initiative
  • Organised, accurate


Contact

We welcome your application and the possibility to evaluate your curriculum!

Fujirebio Europe
Melissa Moens
Technologiepark 6
9052 Zwijnaarde
Tel : 09 329 15 48

 

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