Your job in a nutshell

As QA/RA Officer, you will provide full support to the Director QA/RA to develop quality products. You will manage QA/RA processes and relevant KPIs within QMS and applicable regulatory framework and support the company and non-QA/RA functions with QMS/IVDR related requirements and issues. You will develop, maintain, and improve SOPs and monitor compliance to SOP’s, conduct internal audits and keep the eQMS up to date. You will contribute to preparing the organization for an audit by external parties.

You will perform your work from our offices in Rotterdam (hybrid work model) and be reporting 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

• Responsible for the implementation and coordination of QA/RA related processes.

• Coordinate and follow up on investigating and resolving, track and trend customer feedback/complaints, non-conformities and SCARs.

• Conduct QA review and performs routine monitoring of suppliers within supplier management, and maintain an up-to-date approved suppliers list.

• Support/lead Product and Process Risk Management.

Provide regulatory input to product or projects, conduct or coordinate QARA deliverables in projects.

You have

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

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

• knowledge of IVDD/IVDR and ISO standards e.g. ISO13485, ISO14971, IEC 62304, and IEC 62366, or GMP/GDP/GCP.

• experience with an electronic QMS system.

• experienced in writing and reviewing quality and regulatory documents.

• hands-on experience in deviation, non-conformance, complaints, CAPA and change control handling

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

• experience with quality evaluation of laboratory test results and batch records.

• preferably experience in technical documentation or DHF/DMR.

• communication skills and a creative approach to problem solving.

• an excellent command of the English language.

• 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!

** When applying to this position, applicants grant their permission for the processing of their personal data by SkylineDx only insofar as the processing is necessary for the recruitment process ( to screen their resume and judge their suitability to progress to an interview. Personal data will be deleted by SkylineDx no longer than 4 weeks after the recruitment process has been closed, unless applicants explicitly provide consent to SkylineDx for storing their resume for a longer period of time.**