Quality Manager: in Medical Device Software (80 – 100%)

About the job

Quality Manager: in Medical Device Software (80 – 100%)

Shape the future of healthcare with us.

At CISTEC, we develop and operate KISIM, one of the leading clinical information systems in Switzerland. Our product supports medical professionals, nursing staff, and specialists in everyday clinical practice – from regional hospitals to university hospitals, from psychiatry to rehabilitation. What drives us is the conviction that good software relieves people and improves patient care.

Grow with us.

From our beginnings with two employees, we have developed into a market-leading IT company with over 250 dedicated professionals – and we continue to grow. Here, competence, team spirit, and passion come together. If you want to be part of a success story that shapes the Swiss healthcare system daily, then you are exactly right with us.

Innovative together. For more time with people.

Your tasks

• Participation in the establishment, review, and further development of the QM system including compliance with normative and legal requirements for the QM system.
• Participation in risk management.
• Training of employees in the quality management system.
• Handling improvements, deviations/complaints, and CAPAs.
• Conducting internal audits and supplier audits.
• Participation in post-market surveillance (PMS), handling vigilance reports.
• Contribution to quality management and/or regulatory and/or other projects and processes (depending on interest and experience).

Your profile

• Completed education in computer science, medical or natural sciences, or comparable experience.
• Professional experience as a quality manager, risk manager, or in a similar role in the medical device industry (ideally Software as a Medical Device) and knowledge of regulatory and normative requirements (MepV/MDR, MDCG, ISO 13485, ISO 14971, IEC 62304, IEC 62366).
• Ideally experience and/or further training in internal audits, supplier audits, medical informatics and agile software development, PMS, vigilance system.
• Enjoyment in moderating workshops and collaborating in interdisciplinary teams.
• You appreciate and practice a systematic and transparent working style and like to contribute to a team.
• Fluent language skills in German and English, both spoken and written; French skills are a plus.

We offer you

Meaningful work with impact: You work on exciting projects at the interface of AI and healthcare – in an interdisciplinary team that creates real added value.

Innovative environment: Together we develop pioneering solutions that sustainably improve clinical everyday life – with noticeable impact for health professionals.

Flexible working: Part-time work, flexible working hours, and home office are a matter of course. After the probation period, you can work remotely up to four days a week.

Learning and innovation culture: We actively promote your further education and support you in attending professional conferences and trade fairs. Flat hierarchies and an open, agile team environment create space for personal and professional development.

Attractive benefits: Enjoy 5 weeks of vacation per year. Unpaid leave is possible by arrangement.

Shared experiences: We celebrate successes together – at lunch barbecues, on snow days, or at our team and company events.

Application

Please send your complete application documents by e-mail to: moc.cetsic@gnubreweb

Note for recruiters and headhunters:

We kindly ask you not to send us applications from headhunters or recruitment agencies. Thank you for your understanding.

Diversity and inclusion:

CISTEC stands for equal opportunities and diversity. We welcome applications from all people regardless of personal characteristics or backgrounds.