Targeted & controlled bone healing
The Kuros bone repair products are sold in the US and EU market and QC activities are increasing as production is up-scaled to meet market demand. The small, dynamic Kuros team is committed to offer high quality products and services and is therefore looking for two new team members that fit this spirit.
If you're interested in either of the positions below, please apply in English to: vacancies@kurosbio.com
Manufacturing Team Lead - Bilthoven, Netherlands
Duties and Responsibilities:
- Oversee of daily operations in assigned manufacturing areas, but also able to perform complex manufacturing operations proficiently.
- Ensure compliance with good manufacturing practices, safety standards, manufacturing work instructions, and corporation policies
- Lead team to deliver product on time and within quality standards
- Train, supervise, evaluate, and develop team members. Advocate for team members
- Monitor key performance indicators and take action to correct and document (planned) deficiencies
- Take ownership of the successful execution of the operating plan
- Initiate and support continuous improvement activities
- Monitor and report on process yields, cycle time.
- Highlight non-conforming products and/or processes.
- Liaison between the production and other departments(i.e. R&D, Quality assurance/Control, Supply Chain, etc.).
- Other duties as assigned
Qualifications and Required Skills
- Experience with working in a laboratory and GMP manufacturing environment (incl. clean rooms)
- Aptitude and desire to drive a multi-disciplined work cell to achieve high levels of efficiency and effectiveness while maintaining excellent morale across the team
- Experience solving problems using structured root cause and corrective action methods
- Manufacturing process and equipment troubleshooting experience
- Passion for leading others to achieve significant goals
- Successful time management skills with ability to coordinate resources to meet operating plans per schedule
- Strong interpersonal and mentoring skills
- Willingness to spend extended periods of time in manufacturing areas or cleanrooms
- Self-starter with excellent verbal and written communication skills (Dutch and English)
- Continuous improvement mindset
- Understanding of quality compliance standards (i.e. ISO)
- Familiarity with SPC
QC Technician, Bilthoven, Netherlands
Essential duties and responsibilities:
In a small but dedicated team you are responsible for
- 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
Skills and abilities desired:
- HLO or equivalent
- 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, pro-active and analytical
- Good interpersonal and communication skills are necessary
Why work here?
Kuros Biosciences offers a unique international innovative working environment for highly qualified and motivated individuals with excellent communication skills. We value personal initiative and a sense of humour is much appreciated. The position is Bilthoven based. We have a fantastic team of colleagues and our facility is located in the unique Berg en Bosch business park in Bilthoven. On a weekly basis we organize boot camps and if you like you can even join our running team. Our remuneration package is competitive and can be tailored to meet your specific needs.
