QC Technician
Fulltime
Location: Bilthoven, The Netherlands
Department: Quality Control
Join Kuros Biosciences and help advance the future of the future of orthobiologics for spinal fusion surgery. We’re looking for a QC Technician to support our Quality Control and Quality Engineering team. This is a key position within our Quality Control team in Bilthoven.
About Kuros Biosciences
Kuros Biosciences is a Swiss-listed life science company specializing in orthobiologics for spinal fusion surgery. With locations in Switzerland, the USA, and the Netherlands, we manufacture our bone repair products in Bilthoven and sell them worldwide. We are seeking an experienced Senior QA Officer to join our growing Quality Assurance team in Bilthoven.
Position Overview:
Responsible for planning/coordinating testing and inspection activities related to company products, and recording, analysing and approving results during product development and manufacturing. Also responsible for environmental monitoring activities.
Key Responsibilities:
- Coordination and planning of internal and external QC testing
- Performance and reporting of inspection and testing of raw materials, production related materials and company products (intermediate and finished products)
- Sampling of (raw) materials and products for inspection & testing
- Release of raw materials and production related materials
- Coordination, planning, performance and reporting of environmental monitoring (EM) of production areas and utilities
- Coordination, planning and testing of samples relating to shelf life and validation studies
- Calibration and maintenance of QC and EM related equipment, and maintenance of QC laboratory/areas
Technical:
- Sampling of incoming (raw) materials, (final) products, shelf-life and validation samples
- Plan, perform and report inspection & routine testing of incoming materials and products
- Release of incoming (raw) materials
- Plan, perform and report testing in relation to shelf-life and validation studies where required.
- Communication with external test laboratories with regard to planning, execution and reporting of testing
- Shipment of samples to external test laboratories
- Inspection activities relating to product labelling
- Implement and maintain QC databases, in order to ensure that relevant information is up to date and accessible to relevant functions.
- Initiate and/or review Quality Indicators (Qis), including, but not limited to, deviations and out of specification reports, as necessary, in relation to QC activities
- Coordinates, plans and performs equipment calibration and maintenance activities with regard to equipment for QC and EM purposes
- Training of any existing and new QC personnel, as required
- Coordination and planning of Quarterly Dose Audits (QDA)
- Maintenance of equipment files relating to QC equipment
QA/QC/Regulatory:
- Write and/or review or approve quality control procedures and related documentation, including but not limited to specification documents and testing procedures
- Knowledge of relevant quality control requirements. Keep up-to-date on QC related topics and share information with colleagues.
- Suggest possible improvements to current testing and identify needs for changes in the Quality Management System.
Safety/Organizational/Productivity:
- Know, understand and adhere to all safety standards, i.e., emergency preparedness, chemical, infectious agents and radioactive hazards.
- Participate in the introduction and evaluation of new procedures, supplies and equipment to the extent necessary for proper and safe performance of work activities.
- Ensure proper training of colleagues, students, etc. as necessary
- Use resources (equipment, disposables, time) in a responsible, cost-effective manner.
Qualifications and Experience
Education:
HLO or equivalent.
Experience:
Knowledge of relevant quality systems and regulatory requirements Must be able to work well independently, as well as being able to work cooperatively in a team of professionals. Good working knowledge of ISO 13485 / ISO 9001 / cGMP (FDA 21CFR820- QSR) requirements and relevant technical experience relating to testing of medical devices or/and similar products. Good English skills (written and spoken). Accurate and pro-active. Good interpersonal and communication skills are necessary.
Why Kuros Biosciences?
Join an international, innovative company with a diverse and energetic team. At Kuros, you’ll work in a positive and collaborative environment, contributing to the development of life-changing products. We offer great benefits, a competitive salary, and opportunities for career growth.
