QA Engineer (NL)

 

Your job in a nutshell

As QA Engineer, you will provide full support to the Director QA/RA to develop quality products. Assists the Product Development and Operations teams to develop and manufacture a product within the QA and RA requirements. You will create processes and procedures to define the requirements and actions to be taken from a Quality Engineering perspective. You will provide support with operational process validations, CAPA, Deviations, Change Controls, and Process Improvement(s).

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 fields.

  • > 3 years of experience as a QA Engineer in a medical device, in-vitro diagnostic device company and/or in the pharmaceutical industry.

  • experience in writing and reviewing product development (Quality Operational) related documents.

  • experience in quality planning, Process validations and Product industrialization.

  • experience in supporting audits (as required), deviation, non-conformance, CAPA, risk management and change control

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

  • experience with Process Improvement tools, eg Lean, Agile, Six Sigma, Kaizen

  • experience with Software Development.

  • strong analytical skills and creative approach to problem solving.

  • 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) at hr@skylinedx.com. If you have questions or want more information, don’t hesitate to contact us. You’ll find the contact details here on our website. We will make sure it lands on the right desk!