QA &

Field Specialist (NL)

 

Your job in a nutshell

As a QA & Field Specialist, you are the main QA contact for customer facing related processes and provide full support to the QA/RA Director in analysis and troubleshooting of product/process related issues. You are also responsible for keeping the QMS system up to date and coordinating the implementation of an electronic quality system that meets regulatory requirements. The role will build technical credibility with customers by providing scientific and strategic support for implementation of SkylineDx products. You serve as the customer’s primary technical point of contact and ensure their overall satisfaction with the products, services and support provided by SkylineDx. It is a customer centric role covering technical questions, feedback and/or complaints. The activities are mainly for technical responses, developing technical content, and hands-on training to end users together with the quality - and commercial development team, as well as investigating and resolving the customer's technical, quality and product related questions. This role is the bridge between the customer and the internal stakeholders.


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 or Master degree in the life science area or another relevant clinical area.

  • experience with GMP (good manufacturing practice) and/or ISO 13485:2016 and/or ISO 9001:2015, diagnostic laboratories (ISO 15189) or Testing and Calibration laboratories (ISO 17025) is a pre.

  • experience (> 2 years) as a QA/RA Officer or Field Specialist in a medical device or in-vitro diagnostic device company, or in the pharmaceutical industry.

  • experienced in writing and reviewing QMS documentation.

  • experience on Quality Processes (e.g. Complaints, PMS, Vigilance, Change Control).

  • experience on customer facing communication and troubleshooting.

  • experience with an electronic QMS system.

  • a strong quality and commercial attitude.

  • strong analytical skills and creative approach to problem solving.

  • demonstrated verbal and written communication, interpersonal and presentation skills.

  • the ability perform the work independently with minimal supervision.

  • an excellent command in written and spoken English.

  • 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 Jenevieve Haas (HR) at info@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!