Quality Affairs Manager (f/m/d, 60-100%)
hemotune AG is a multi-award winning Swiss medical device start-up company originating from ETH Zurich. Our mission is to develop a life-saving breakthrough medical device for targeted blood purification, and we are currently in the preclinical development phase. To support our team, we are looking for a:
We offer the unique opportunity to be a part of a dynamic award-winning and highly motivated start-up team and to develop a live-saving therapy. Due to the various nature of the devices in scope (active as well as substance-based MDs), the position includes a wide range of tasks and responsibilities. In addition, the small size of the company and the flat hierarchies allow for continuous and non-bureaucratic improvements of the relevant procedures. The modern workplace is located at Bio-Technopark Schlieren, 20 min from Zurich HB by public transport.
Your responsibilities:
- Ensure the adherence of QMS requirements in the medical device development, production, and post-marketing phase (active as well as substance-based medical devices; Class IIa-III)
- Main QA responsible for in-house testing and production activities in the laboratory environment
- Support of product releases and process improvements
- Handling of change management and CAPAs
- Supplier and infrastructure management
- Support of complaint management
- Ensure the employees’ qualification incl. trainings
- Support of regulatory submissions and audits by regulatory authorities
Requirements:
- University degree in natural sciences or engineering
- Relevant work experience (> 3 years) in the medical device industry in quality management, knowledge in production or laboratory management is a plus
- Familiar with EN ISO 13485 or GMP; knowledge of 21 CFR 820 if possible
- Experience in working in a chemistry or biology work environment is a plus
- Excellent verbal and written communication skills in German and English
- Quality thinking, analytical and structured work, problem-solving skills
- “Roll up your sleeves” attitude, ability to work in a multidisciplinary, multinational team
For further information please contact us (Write an email) and/or learn more about us on www.hemotune.ch.
We are looking forward to receiving your online application with the following documents: CV, motivation letter, diploma, credentials.
Please submit your application online.
Kontakt
Ursina Haltinner
Head of Regulatory & Quality Affairs
Write an email
Website
Schlieren / Zürich