If you are looking for an interesting and diverse job, which offers a high degree of influence and development in a company that makes a big difference in the diagnosis of cancer, then we are also looking for you. The Quality Assurance Process Engineering team are looking for a QA Validation Specialist.

Our mission is to help our customers around the world to fight cancer and other life-threatening diseases. We aim at providing the best solutions to ensure accurate and early diagnosis, and to improve treatment and enhance survival rates.

About The Team
The QA Process Engineering team is situated in the heart of pathology QA. Our goal is to strengthen the focus on the complete pathology solution to the benefit of users and patients. We have a dedicated user focus, and you will have a high influence on the design, production and distribution of our products to ensure safe and effective workflows.

The position

You will work with Validations, Risk assessments, change control and control charting. You will work side by side with the QA Process Engineering team and will collaborate with other teams in QA, Project Managers, Subject Matters Expert from R&D, Manufacturing, Logistics, Marketing and Sales. Ideally, you have previous experience in Quality Assurance, Risk assessment and Validations in the medical device/pharma industry and are familiar with ISO13485:2016, 21CFR820, MDSAP Audit Model, IVDR.

• Participate in projects as QA Validation Specialist related for New Product development and Design transfer activities
• Drive the assigned validation activities in collaboration with Manufacturing and R&D
• Ability to effectively interface with stakeholders
• Support the internal trainings in relation to validations
• Approval of Risk Documentation (e.g. FMEA) and Process Validation Master Plans and related change request processes
• Re-qualification/re-validation activities on current production processes and related documentation
• Support review and approval of Process monitoring (control charting)
• Review of procedures, work instructions, standards maintenance documents or master documents describe critical parameters or ranges determined in validation studies.
• Give input to Improvement of procedures for validation to fulfil internal and external requirements, ensuring validation documentation content meets the current regulatory requirements
• Give input to overall Site Validation and control charting strategy
• Software validation experience will be an add-on