QA / RA Officer (NL)

 

Your job in a nutshell

The QA/RA Officer provides full support to the Director QA/RA to develop quality products. Assists the lab and supervises the handling of deviations or other QA issues. Assists other staff in the company with QA related issues. Creates SOPs for QA related topics and monitors compliance to SOP’s. Conducts internal audits and keeps the QMS system up to date. Organizes the Management Review and trains employees in QA related topics. Prepares the organization for an audit by external parties.

 

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

 

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. 

 

You have

  • a Bachelor’s or master’s degree in life science related topic.

  • experience (> 3 years) as a QA/RA Officer in a medical device or in-vitro diagnostic device company, or in the pharmaceutical industry.

  • experience in writing and reviewing quality, and design and development related documents.

  • experience in quality planning, auditing, hosting audits and inspections.

  • experience in deviation, non-conformance, CAPA and change control handling.

  • experience with quality evaluation of laboratory test results.

  • demonstrated experience with successfully implementing relevant quality system regulatory requirements with respect to at least GMP (good manufacturing practice), or ISO systems.

  • additional experience with implementing quality system regulatory requirements.

  • experience in developing QA-related forms in an eQMS, in Excel or Word (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 Soraya Mestar (HR manager) at hr@skylinedx.com. 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!