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QA Design Officer Almere QTC Recruitment

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Gevraagd

  • 40 uur
  • Engels (taal)

Aanbod

  • Vast contract
  • 13e maand
 

Vacature in het kort

Almere
Join a dynamic and growing specialty medical device company as a Technical QA/RA Design Specialist. Play a pivotal role by managing the technical file process, leading updates per MDR, and overseeing supplier activities. Engage in international regulatory support, present technical documentation during inspections, and handle risk assessments. Enjoy a competitive salary, a 13th month bonus, and gain valuable experience in a highly regulated class III environment. Uncover the reasons why this position could elevate your career.
 

Over het bedrijf

QTC Recruitment
Werving en selectie
Bedrijfsprofiel
 

Volledige vacaturetekst

QTC are partnered with a growing speciality medical device company creating and manufacturing a class III product via an aseptic process within the aesthetic specialism. Products are designed and produced in-house before being distributed through a global network of suppliers. The business are experiencing continued growth and are looking for a new member to join their quality and regulatory function.


This is how you will make the difference
Our client are searching for a technical QA/RA Design Specialist to join their team on a permanent basis. The role will focus on owning the technical file process including leading relevant updates based on MDR, maintaining documentation history and controlling suppliers of technical file activities. Additional activities will include: Providing international regulatory support throughout the product life cycle. Presenting and defending technical documentation during regulatory inspections. Complaint handling and root cause investigations. Handling risk assessments along with project/change management.

What you bring

Requirements:

  • You hold at least a bachelor's degree in a technical or medical field

  • Relevant experience in the medical device of pharmaceutical industry

  • Extensive knowledge of MDD and MDR.

  • Possess strong technical writing and communication skills 

  • Working command of English language

  • Experience working within smaller cross-functional teams beneficial


What's in it for you

Offer:

  • Varied and dynamic role in a growing organisation

  • Competitive basic salary with additional benefits

  • 13th month bonus

  • Transferrable experience in a highly regulated class III environment 


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