Based in
Zurich, Switzerland
100%

Paul

“At Skope I have been asked to contribute to the company in significant and impactful ways, and achieving this meaningful challenge has been immensely satisfying. Each person is critical to the success of Skope!”

GM Skope MR Inc & Sales Director North America and China

Your Role

In this dual role you will support our Operations Team at Canon Medical Systems Switzerland in Wallisellen as well as our sister company Skope AG in Oerlikon. You will ensure that all regulatory as well as quality requirements are met and that policies, processes, instructions and forms in the quality system effectively support the business needs.

Your Tasks

  • Ensure expedience, effectiveness and efficiency of the implemented quality policies and systems in compliance with all legal and corporate requirements (e.g. ISO 9001:2015, ISO 14001, MepV, MDR, MDD)
  • Actively support the development, description and documentation in the quality system of all relevant policies, processes, instructions and forms
  • Coordinate and lead audit activities with external and internal auditors
  • Drive implementation of an ISO 13485 compliant quality management system at Skope
  • Guide and support Skope R&D with the generation of technical documentation required for MDR conformity (e.g. IEC 60601, IEC 62304, IEC 62366, ISO 14971)
  • Lead regulatory affairs to ensure product access to the market
  • Ensure local product launches and commercial activities comply with legal and regulatory requirements
  • Monitor and anticipate changes of relevant laws and regulations (Swiss and international)

Your Profile

  • A completed technical, medical or science education at university level or equal
  • Additional training in the field of quality management of medical devices
  • Several years QA/RA experience in Swiss or international Medical Equipment or Medical Device Industry
  • A solution-oriented, assertive personality with a high sense of responsibility
  • An authentic team player with a positive mindset and a constructive approach
  • Very good knowledge of written and spoken German and English
  • Familiarity with quality management software and MS Office Suite

Your Prospect

  • A familial and appreciative atmosphere in two growing international companies
  • The opportunity to contribute your ideas and support the further growth of the companies
  • A modern working environment with numerous benefits including a company car for private use
  • An interesting and very multifaceted job with a big responsibility
  • In-house trainings, e-learnings and on-the-job trainings

Miriam Hauser

Our VP HR Miriam is looking forward to receiving your application. Please send us your CV, motivational letter and certificates to introduce yourself.

VP HR