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03.05.2021

Teamlead Product Compliance and Documentation (m/f/d), Heerbrugg (Switzerland)

  • 9435Heerbrugg
  • Vollzeitstelle

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From Eye to Insight
Leica Microsystems (Schweiz) AG ist Teil des internationalen Leica Microsystems Konzerns, einem der weltweit führenden Unternehmen für Mikroskopie- und Labortechnologie. Seit 2005 gehören wir zur erfolgreichen US-amerikanischen Danaher Gruppe. Am Schweizer Standort in Heerbrugg entwickeln und vermarkten wir Operationsmikroskope für medizinische Anwendungen sowie digitale und Stereomikroskope. Die konsequente Weiterentwicklung unserer innovativen Produkte macht Leica Microsystems zu einem erfolgreichen, weltweit agierenden Unternehmen in führender Marktposition.
From Eye to Insight
Leica Microsystems (Schweiz) AG ist Teil des internationalen Leica Microsystems Konzerns, einem der weltweit führenden Unternehmen für Mikroskopie- und Labortechnologie. Seit 2005 gehören wir zur erfolgreichen US-amerikanischen Danaher Gruppe. Am Schweizer Standort in Heerbrugg entwickeln und vermarkten wir Operationsmikroskope für medizinische Anwendungen sowie digitale und Stereomikroskope. Die konsequente Weiterentwicklung unserer innovativen Produkte macht Leica Microsystems zu einem erfolgreichen, weltweit agierenden Unternehmen in führender Marktposition.

You will be responsible for leading the Product Compliance Team for the Medical and Applied Business Units. Furthermore, you will check the product compliance of devices and systems as well as their documentation within the framework of the Leica strategy. Due to project specifications, European and international regulations for market access and product safety you will ensure that our products comply with the standards and the necessary documentation.

Teamlead Product Compliance and Documentation (m/f/d), Heerbrugg (Switzerland)

Your task:

  • Close cooperation with Marketing, R&D, Industrial Engineering and Regulatory Affairs & Quality Insurance. 
  • Documentation, testing and approval of systems to ensure product compliance, market access requirements and product safety.
  • Contact person for external testing institutes (TÜV, UL, etc.) regarding our product range. Coordination of tests at external testing institutes, elaboration and implementation of necessary modifications to achieve normative requirements.
  • Creation, monitoring and maintenance of test reports, technical documentation, document templates, concepts and versions for the compliance file (test reports, checklists, manuals, overview lists, etc.).

Your qualifications:

  • University degree in technical sciences or engineering with a focus on electronics and mechanics.
  • Several years of professional experience in a comparable position e.g. in Product Compliance or Technical Documentation.
  • Proven experience in the product segment of technologically sophisticated products ideally in the field of microscopy or robotics.
  • Ideally knowledge of product relevant laws and standards: European Low Voltage Directive, Electro Magnetic Compatibility, Medical Devices Directive and regulatory requirements in:  MDD (93/42/EEC) and Risk Management (ISO 14971).
  • Experience in management of people.
  • Experienced to work in interdisciplinary teams.
  • Language skills: fluent German and English.

What we have to offer:

  • With us, you can expect varied, challenging tasks that you can master with great colleagues at your side.
  • Flexible working hours and partly home office.
  • As part of the Danaher Group, you will have access to exciting internal programs for promotion and further development.

Arbeitsort:

9435Heerbrugg

Are you interested in working in a dynamic and team-oriented environment and are you ready to break new innovative ground with us? Then apply online with your complete documents (cover letter, resume, references) and your salary expectations.
We look forward to receiving your application!