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Quality Affairs Manager (f/m/d, 60-100%)

bewerten
Bewertung abgegeben
14.03.2024 60% - 100% Festanstellung
Arbeiten bei hemotune AG
hemotune AG

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:

Quality Affairs Manager (f/m/d, 60-100%)

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

Ursina Haltinner

Head of Regulatory & Quality Affairs

Write an email


Website

https://www.hemotune.ch

Über die Firma

Schlieren / Zürich

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