Quality Assurance Manager (100%)


Quality Assurance Manager


Quality is everything! 

For our longstanding and well-known client, Roche Diagnostics International AG, we are looking for support for a long-term temporary assignment in Rotkreuz as a

Tasks & Responsibilities:

The Quality Assurance Manager Operations works with Global Operations to ensure that Roche procedures, applicable regulations and standards (regulatory requirements of United States Food and Drug Administration, In Vitro Diagnostics Directive of the European Union, ISO 13485, etc.) are followed during manufacturing. 

The main tasks are:

  • Support and enable the business partners
  • during a time of increasing production volumes
  • regarding product care and product improvement activities as well as in all other quality aspects of the consumables products
  • Ensure product quality and compliance to the regulatory requirements and the proper documentation of all activities
  • Support of business partners by
  • Reviewing and approving documents, changes, deviations
  • Reviewing and approving Q&V activities
  • Releasing Products
  • Ensure improvements through CAPAs, SCARs and process updates
  • Lead and/or support special projects or initiatives in the area of quality and of our business partners
  • Permanently optimize processes in order to increase quality and efficiency standards 

Professional requirements:

  • completed (further) education in med-tech and quality area
  • 5+ years of professional experience with the medical device regulations including ISO 13485 and FDA regulations
  • Strong communication skills in both German and English
  • Quality management experience
  • Able to lead a process improvement project
  • Technical and/or scientific experience and understanding
  • Good stakeholder management skills across all hierarchy levels
  • Knowledge of Injection Molding
  • Technical or scientific university degree is a plus. (Specific education in med-tech and quality area is more important)
  • SAP experience a plus (can be trained after start as well but since team is working with SAP the onboarding will be faster if candidate has already experience) 

What is offered to you:

  • Long-term temporary employment with an option to extend
  • The chance to get involved in one of the most successful pharmaceutical companies in the world
  • Fair, contemporary and punctual remuneration
  • Up to CHF 5000.- participation in further training via temp training
  • A partner at your side who focuses on honesty and quality 

If we have been able to arouse your interest, we look forward to receiving your complete application documents by e-mail to Ms. Saranda Berisha (saranda.berisha@elan-personal.ch). Gladly also in German.