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QA/RA Officer

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The company

At SkylineDx
we live to make a difference. It is our mission to improve a patient’s quality of life by enabling them to benefit from personal insights at the genomic level of their disease. That means we are continuously innovating the world of gene signature-based diagnostic testing. That also means we have a unique blend of characteristics. We have our soft side. Our culture is oftentimes described as familial, warm, loyal and highly engaged. We have our rational side where exact sciences are driving our mission. And when needed our passionate side surfaces to clear the way so we can serve society with science based solutions.


Role description

Your job in a nutshell
As QA / RA Officer you maintain and further develop the electronic Quality Management System (eQMS) that is directed towards the design, development and manufacturing of in vitro diagnostic medical devices and diagnostic testing. You contribute to the expansion of the eQMS by developing and validating new modules, and as a writer to the creation of QA-related documentation. You act as a Document Controller and provide training to your colleagues regarding different aspects of the QMS. Outside the eQMS you will be performing internal and external (supplier) audits, assist in QA-related issues and perform QA-related duties when applicable.


Responsibilities

Together we ensure the validation and implementation of clinically relevant scientific discoveries into reliable medical diagnostic assays for diagnosis, prognosis and drug effectiveness prediction that will ultimately contribute to improved patient care. 


Requirements

You have

  • a Bachelor or Master degree in the life science area or another relevant clinical area.
  • familiarity with working in a QMS in a regulated environment (required).
  • experience in developing QA-related forms in an eQMS, in Excel or Word (required)
  • experience with an eQMS.
  • knowledge of software development (pre)
  • familiarity with deviation and change control management.
  • knowledge of ISO 13485, ISO 27001, ISO 15189, FDA 21 CRF part 820 and/or other quality management standards and regulations that are relevant to the Life Science area.
  • knowledge of EU directive 98/79/EC and/or EU regulation 2017/746 on CE marking of in vitro Diagnostic Medical Devices (IVD) and/or FDA 510(k) clearance or pre-market approval (pre).
  • proven and adequate skills in writing procedures and reports (required).
  • an excellent command in written and spoken English (pre).
  • a hands-on mentality and result oriented attitude.
  • an entrepreneurial mind-set and are able to work in an environment with high quality standards.
  • the ability to motivate the team and manage both internal and external collaborations.
  • affinity with our corporate quotes (must).

 
We offer

  • a full-time position, a market competitive salary and market competitive secondary conditions of employment.
  • opportunities for personal growth.
  • the best of two worlds: a career in life sciences at an innovative biotech company with the emphasis on clinical diagnostics in close collaboration with an academic environment.
  • the ability to serve society with science based solutions.

 
At SkylineDx
we live to make a difference. It is our mission to improve a patient’s quality of life by enabling them to benefit from personal insights at the genomic level of their disease. That means we are continuously innovating the world of gene signature-based diagnostic testing. That also means we have a unique blend of characteristics. We have our soft side. Our culture is oftentimes described as familial, warm, loyal and highly engaged. We have our rational side where exact sciences are driving our mission. And when needed our passionate side surfaces to clear the way so we can serve society with science based solutions.
 
Our quotes
#serviceisjoy

#valueformoney

#playtogethertowin

#amazingthingshappen

#cogitoergosum

#itsyourparty
 
Do apply!
Send your resume and motivation letter to Deborah Wigmans (HR) via the 'Apply' button. If you have questions or want more information, don’t hesitate to contact us. You’ll find the contact details on our website. We will make sure it lands on the right desk!




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SkylineDx B.V.

Listed by: SkylineDx B.V.
Listed on: 02-05-2019
Country: The Netherlands
Region: Zuid-Holland
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Biotechnology
Specialisation: Quality


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