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.

Leica Microsystems is one of the market leaders in the fields of microscopy, imaging, and analysis. We reveal the invisible and empower our customers to create a better and healthier world. Together with our customers, we transform scientific discovery. We empower surgeons to take well-informed decisions in life-changing procedures. We enable users to gain insights which help answer key questions concerning development and engineering. All of this is achieved with the combination of cutting-edge microscopes and AI-based image analysis.

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 following position in our Durham, North Carolina office, which will be a hybrid working arrangement.

QA Manager (d/f/m)

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

YOUR RESPONSIBILITIES

• Ensure that quality system requirements are established and maintained per the applicable regulations.

• 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.

• Provide support during product design and sustainment to establish compliant and audit robust design documentation.

• 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 quality assurance with medical electrical devices in an FDA-regulated industry or an equivalent combination of education and experience.

• Bachelor’s 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 medical device regulatory requirements in the United States and European Union

• You have great communication skills and are available to travel 10% of the time.

WHAT WE OFFER

• Attractive salary and pension package

• Flexible working time modules

• A balance between support and autonomy to achieve your own goals in an international environment

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 where you can work part of the time at the Company location identified above and part of the time remotely from your home. Your interview team will provide additional information about this hybrid work arrangement. Explore the flexibility and challenge that working for Leica Microsystems can provide.

The salary range OR the hourly range for this role is $125,000 to $135,000. This is the range that we, in good faith, believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer eligible employees a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and a 401(k).

Note: No amount of pay is considered to be wages or compensation until it is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits allocable to a particular employee remain in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the 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!

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.

The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.