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QA Engineer

, you will provide full support to the Director QA/RA to maintain effective QMS and develop quality products. You will manage QA/RA processes and relevant KPIs within QMS and applicable regulatory framework; manage eQMS system and relevant QMS tools, and support operational process validations, CAPA, Deviations, Change Controls, and Process Improvement(s).

You will perform your work from our office in Rotterdam (hybrid work model) and report to the Director of QA/RA.
Together, we ensure the translation 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, validation, maintenance, and training of eQMS tool (Zenya).
Manage and maintain QA processes, and coordinates and follow-up on investigations and resolutions required for QA records such as those of feedback/complaints, nonconformities, CAPAs, Deviations.

Responsible for Process Improvement and QA deliverables in projects.
Support Product and Process Risk Management.
Support Product and Process validation and verification.
You have
a bachelor’s or master’s degree in engineering or life science related topic
experience (> 3 years) in a QA engineer or an equivalent role in a medical device, in-vitro diagnostic device company and/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 in eQMS (Zenya) tools or affinity to IT/software engineering is highly desired.
experience in writing and reviewing quality and regulatory related documents.
hands-on experience in deviation, non-conformance, CAPA, risk management and change control.
experience in quality planning, auditing, hosting audits and inspections.
experience with quality evaluation of laboratory test results and batch records.
a result-oriented attitude.
an excellent command of both written and spoken English.
an entrepreneurial mind-set and can 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.
a collective pension plan.
a bonus plan.
a hybrid work model.
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.

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