QA
Specialist (NL)

 

Your job in a nutshell

The QA Specialist is the main QA contact for Supplier related processes, the subject matter expert (SME) for the risk management within the QA/RA department and provides full support of the QA/RA Director in analysis and troubleshooting of product/processes related issues, and the qualification and (re)-evaluation of Suppliers. Is also responsible for keeping the QMS system up to date and coordinating the implementation of an electronic quality system meeting regulatory requirements. Collaborates with internal SME’s to ensure customers feedback and complaints are investigated and resolved within established timelines, including interaction with the complainant, and potentially with local health authorities. Responsible for supplier management including supplier audits and conducting internal audits, manages the supplier corrective action request process and interfaces with internal SME’s and external suppliers to perform problem resolution and issue supplier corrective action requests where appropriate. The role will work with cross functional product development teams to apply Risk Management during all design phases for new products and/or product and/or process updates. The QA Specialist ensures that he/she stays up to date on new regulations and standards that affect QMS system for medical devices and also drives knowledge transfer on related topics to the organization.


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 topics.

  • 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.

  • knowledge of ISO 14971 and familiarity with associated standards (IEC 62304, IEC 62366, etc).

  • experience with an electronic QMS system - Experience (> 2 years) as a QA/RA Officer or 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 (eg Complaints, PMS, Vigilance, Change Control).

  • experience with supplier quality and post-market operational activities.

  • experience conducting audits independently as lead auditor.

  • 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 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 here on our website. We will make sure it lands on the right desk!