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

hemotune AG

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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 phaseTo 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 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 position as QA Manager was newly created (QA team of 3 people). The 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
  • Supporting the in-house device development
  • Supporting the in-house production incl. product releases, process improvements, process validations
  • Managing of supplier qualifications, support qualification and maintenance of infrastructure used for V&V activities & production
  • Ensure the employee’s qualification (training management)
  • Handling of the change management and CAPAs
  • Supporting the cooperation with external CMOs
  • Support of internal and external audits
  • Support of regulatory submissions

Requirements:  

  • University degree in natural sciences or engineering
  • Relevant work experience (> 3 years) in the medical device industry in quality management
  • Familiar with EN ISO 13485:2016 and relevant standards, knowledge of 21 CFR 820 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.

hemotune AG
Frau Diane Lüber
Executive Assistant
+41 77 512 36 98

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