Manager QA/RA (NL)


Your job in a nutshell

As Manager QA/RA you will support the management of the department and supervise the required QA/RA processes. You will act as subject matter expert on In Vitro Diagnostic Medical Device Regulation/ISO 13485. You will maintain medical device quality and regulatory awareness of all relevant functions in SkylineDx, follow ISO/IVDR developments closely and develop and maintain Quality Management System and IVDR compliance. You will support audits as required.

The Manager QA/RA report to the Director QA/RA.

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.  


Essential Duties and Responsibilities

  • Manage a wide variety of QA/RA related tasks to ensure that all of the company’s activities are performed at the appropriate quality level.

  • Improve and maintain the quality system according to the ISO 13485, ISO 14971, ISO 15189 and FDA 21CRF 820 quality system regulations.

  • Manage writing and executing quality related procedures and plans.

  • Manage, organize and execute internal and external audits.


You have

  • a Master’s degree in life science related topic.

  • advanced quality management skills.

  • knowhow of IVDR and ISO regulation.

  • > 3 years of experience in team management positions and preferabily > 5 years in QA/RA roles in a medical device, in vitro diagnostic device or pharma company.

  • familiarity with EU regulation 2017/746 for in vitro diagnostic medical devices and ISO13485 or equivalent is a must.

  • familiarity with FDA guidance documents in relation to in vitro diagnostic product development is a plus.

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

  • experience with implementing relevant quality system regulatory requirements with respect to ISO 13485 or MDSAP.

  • experience in quality operations, e.g. audits and inspections, deviation, non-conformance, CAPA and change control.

  • experience in writing and reviewing CE registration files and IVD submission files under IVD directive/regulation is preferred.

  • experience with evaluation of laboratory test results is a plus.

  • experience in quality or regulatory project coordination and management of timelines.

  • experience in communication with HAs and NBs.

  • strong communication, supervision, and delegation skills.

  • goal-driven, able to deliver and team player.

  • strong analytical skills and creative approach to problem solving.

  • experience with working according to high-quality standards and are able to ensure the products are developed accordingly.

  • an intrinsic motivation to make a positive contribution to health care and provide solutions for patients.

  • a hands-on mentality and result oriented attitude.

  • affinity with our corporate quotes (must).

  • 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.

  • an excellent command in written and spoken English.



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








Do apply!

Send your resume and motivation letter to Soraya Mestar (HR Manager) at 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!