Vacature: Interim | QA RA Specialist | Alphen aan den Rijn Vacature - Alphen aan den Rijn, Zuid-Holland 2408 AV
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Interim | QA RA Specialist | Alphen aan den Rijn
Sakura Finetek Europe B.V.
Quality Control / Security / Safety
Alphen aan den Rijn
32-40 hour
Bachelor - University




Sakura Finetek Europe B.V.

  Quality Control / Security / Safety
   Alphen aan den Rijn
  32-40   
Bachelor - University
Sakura Finetek Group is an international manufacturer and supplier of first class, high quality medical diagnostic products. At Sakura Finetek Europe, we develop, manufacture and sell histological and cytological instruments and consumables.
 
We have achieved our success and solid reputation by providing timely, well-thought-out solutions to help solve the everyday challenges that laboratories face. Time for change!. Currently, about 260 staff members work at our various locations throughout Europe. This is ‘our story’.
 
We are looking to hire an energetic

Interim | QA RA Specialist | Alphen a/d Rijn
6 months, 4/5 days a week, hourly rate €75 - €80


Why?
 
The quality management system needs perfecting!  

What?

-> Ensuring technical files are compliant & product development principles are followed
-> Ensuring compliance with WEEE, REACH & RoHS
-> Leading investigation of non-conformities
-> Development of procedures, work instructions & policies
-> Assuring all procedures & quality records reflect the current way of working

How?

-> Help improve IVD instrument technical files & sustainment activities
-> Promoting a collaborative atmosphere of quality awareness
-> Collaborate with all stakeholders throughout the organization
-> Act as a QA/RA ambassador

Reports directly to & liaises with the Manager QA RA.
 
 You will be responsible for

  • ensuring product development and new product introduction activities are compliant
  • supporting Quality Management System (QMS), Quality Assurance, ISO compliance & certification
  • developing, maintaining & regularly assess key policies and procedures to mitigate identified risks & meeting government and healthcare compliance requirements
  • promoting a positive culture surrounding Quality, Regulatory & Continuous Improvement
  • keeping all stakeholders up to date


 You have solid experience in

  • Quality Assurance and Regulatory Affairs within the medical devices industry
  • the MDR / IVDR regulatory affairs area
  • WEEE, REACH and ROHS directives
  • ISO 13485


the ability to

  • connect easily & make an impact at all levels


You

  • live in The Netherlands and feel at home in an international environment
  • are self-organised, structured and independent
  • can express yourself fluently in Dutch & English
  • reach out, team up, and deliver!

Interested in speaking to us?

Does the above appeal to you? Apply today using our Online Application Form. Website: www.sakura.eu

Should you require any further information regarding this vacancy, please do not hesitate to contact Imane Azriyaa (Corporate Recruiter) i.azriyaa@sakura.eu

Apply


Acquisition? Please don't!

Contact information
Sakura Finetek Europe B.V.
Imane Azriyaa

Website: Go to website