CAScination AG is a fast-growing and award-winning medical technology company dedicated to the development, manufacturing and commercialization of innovations in computer-assisted and image-guided surgery. Our mission is to improve medical interventions by establishing robotics and navigation technology as standard of care. Our products enable doctors to perform highly precious, reproducible and efficient treatments and give patients access to minimally invasive and effective therapies.
For our team in Bern, Switzerland, we are searching for a
Quality Assurance Manager - (m/f, 100%)
In this position, you are responsible for maintaining, further development and effectiveness of the quality management system. You are leading quality assurance activities related to all CAScination products (class I/IIa devices) within the company and with external partners/authorities.
- Establish, manage and maintain compliance with ISO 13485:2016, the European MDD, the upcoming European MDR and FDA QSR
- Act as the point of contact in front of Competent Authorities and other external parties for all quality communication.
- Own and maintain the Quality Management System, including establishing and updating procedures and forms.
- Lead and be responsible for quality assurance for all products for which CAScination is the legal manufacturer.
- Monitor compliance with the procedures. Perform internal and external audits.
- Support the selection and implementation of IT support infrastructure and tools to facilitate QA related processes.
- Support Regulatory Affairs and Risk Management activities
- +3 years of similar QA Management experience in a medical device company.
- Minimum Bachelor’s degree in science, engineering or healthcare, with an additional degree in Quality Management (or similar experience).
- Experience with common medical device standards (e.g. ISO/IEC 13485, 14971, 10993, 60601, 62366), CE marking and 510(k).
- Excellent communication skills with all the key stakeholders to ensure QA vision is understood and implemented correctly.
- Decision-maker, quick thinker, proactive and strong-minded.
- English fluent, German is a plus.
If you are interested in a challenging position where you can have a major impact on the development and commercialization of novel robotic and navigation technologies, then join our dynamic team, operating in a fast-paced and international environment. We offer you with competitive compensation and benefits, and a great culture in a company advocating equal opportunities.
We are looking forward to receiving your application* (CV, Motivation Letter, Working References, Diploma, etc.).
JOBS@CASCINATION.COM, Phone Stefan Aebischer +41 31 552 04 30
* Applications from recruitment agencies will not be considered.