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Hybrid

Quality Engineering Specialist (m/f/d)

Leica Microsystems · Heerbrugg, Sankt Gallen, Schweiz

Online seit 2023-03-24 13:00:00.0

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For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success.


Want to be part of a company whose products are part of cutting-edge research around the world? Join Leica Microsystems in our commitment for brilliant solutions and insight.


Leica Microsystems is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.


We currently offer the position as Quality Engineering Specialist (m/f/d) in our office in Heerbrugg, Switzerland. The position can be hybrid (office/home office). You will be part of the Quality & Regulatory Affairs department within the Medical BU and will report to Senior Manager CAPA & Vigilance.


Your Responsibilities


  • Review and analysis of customer complaints and ensure that complaint investigations are performed and documented adequately
  • Responsible to lead and drive quality related projects (DIVE) for product quality and reliability improvements by applying the CDT&R approach
  • Actively advise, support and coordinate with other departments such as research & development, product management, industrial engineering, operations incl. sales and service, marketing and other related departments which contribute to product improvement projects
  • Supports the Senior Manager CAPA & Vigilance in CAPA Projects by providing investigation results as well as supporting the documentation and coordination of CAPAs
  • Support during internal and external audits


OUR EXPECTATIONS


  • Technical degree in medical engineering, science, engineering, biomedical engineering or equivalent education (technician)
  • Few years of relevant regulatory and/or quality assurance experience with electrical medical devices in a regulated industry or equivalent combination of education and experience
  • Proficient knowledge in problem solving, complaint handling and/or technical investigations
  • Thorough technical knowledge required (electronic, software and hardware)
  • General knowledge of medical device regulations applicable to MDSAP countries (TGA, ANVISA, Health Canada, MHLW/PMDA, FDA as well as ISO 13485
  • English language skills are essential, German is a plus


It would be a plus if you also possess previous experience in:


  • Surgical operating microscopes or similar experience
  • Medical electrical devices risk evaluations
  • Working in an international matrix environment
  • Thorough knowledge in medical device development incl. software development


GET MORE INSIGHT


Learn more about what we do and who we are by watching our company video “We Are Leica”: https://www.youtube.com/watch?v=1zHmalqMXN4


At Leica Microsystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Microsystems can provide.


When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.


At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.


If you’ve ever wondered what’s within you, there’s no better time to find out.
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