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Danaher Corporation Quality Assurance Engineer in Heerbrugg, Switzerland

Leica Microsystems has helped shape the future of microscopy for over 170 years 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 proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

For our office in Heerbrugg, Switzerland, in a hybrid working module, we are looking for a:

Quality Assurance Engineer (d/f/m)

In this exciting role you are responsible for all aspects of quality assurance during design, development, design transfer and design changes of Leica Microsystems medical devices.

If you have great communication skills, a strong focus on quality, hands on mentality and a passion for effective QMS as the foundation of high-quality products and services we are looking forward to your application.

YOUR RESPONSIBILITIES

  • Ensure adequate application of design control requirements during new product development and throughout the product life cycle

  • Review QMS relevant design control documentation including design transfer and design change documentation

  • Support R&D and Product Management to establish compliant and audit robust design documentation

  • Support the QA Manager and project leaders during audits as subject matter expert for technical documentation

  • Perform audits and design transfer reviews

  • Ensure technical documentation is adequate for product registrations and support when needed

  • Perform training on QMS requirements related to design control including design transfer and design change procedures

YOUR PROFILE

  • You have gained proven experience in QMS and/ or QA experience with medical electrical devices in an FDA-regulated industry or an equivalent combination of education and experience

  • BSc degree (BA/BS) or equivalent in science, engineering or equivalent

  • You have experience in a global/ matrix environment or cross-functional teams in the medical device industry

  • Knowledge of US and EU medical device regulatory requirements

  • You have great communication skills in English, German is an advantage (written and spoken) and you are available to travel 10% of the time

  • Team player with the ability to work alone and strong analytical, organizational skills

  • You have strong problem-solving skills, are well organized, able to see the bigger picture and bring a high level on integrity

WHAT WE OFFER

  • We offer an attractive salary and pension package

  • Our employees have the option to work from home up to 2 days/week

  • We enable independent work and empowerment within a committed, international team

  • Equal pay is a matter of course for us

  • We support our employees in their professional and personal development

  • With us you get the chance to successfully contribute your own ideas

DIVERSITY AT LEICA

We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

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

Are you interested to discover new opportunities in an innovative, team-oriented environment?

Do apply online - we are looking forward to your application!

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 (https://www.danaher.com/how-we-work/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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