Lead Principal Specialist, Quality Assurance and Regulatory Compliance Service

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Leica Biosystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact.

Learn about the Danaher Business System which makes everything possible.

The Lead Principal Specialist, Quality Assurance and Regulatory Compliance Service role will provide Quality & Regulatory support and leadership to maintain, improve, and support processes to ensure compliance with applicable regulations and standards executed globally at the Selling Unit (SU).  This individual acts as a pivotal point of contact and alignment between the Leica Biosystems (LBS) SUs and the Leica Biosystems Business Units (BUs), to ensure compliance. This position will also lead the quality activities at the SU service and repair shop out of the Richmond, IL location.

Major Responsibilities

• Establish and maintain Quality requirements at the LBS SUs Globally including training (example: complaint handling, adverse event escalation, recall, product classification, and product claims), execution of field action activities, and ensuring compliance of the Service and Installation records.
• Establish and maintain Quality requirements at the Richmond SU Service and Repair shop including proper processing of the medical devices, and training to the QMS procedures.
• Lead as the core representative for internal and external audits of both the SU QMS and the Richmond SU Service and Repair Shop
• Serve as Project Manager for designated improvement projects.
• Effectively use Danaher Business System (DBS) tools to drive continuous improvement.

Skills/Experience

• Bachelor’s degree in science, medical or technical field required
• 7+ years’ work experience with increasing responsibility in medical device/IVD Quality Assurance showing extensive knowledge of medical device quality systems including but not limited to 21 CFR 820, MDSAP, ISO 14971 and ISO 13485 required  
• Experience with problem-solving and continuous improvement tools required
• Specific experience in driving compliance of quality systems required.
• Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams and regulators. 
• Certifications preferred: Quality Management, Quality Auditor, Lead Auditor, Six-Sigma Black Belt, Quality Engineer

Travel % of Travel, include approximate overnight stays per week

• Travel expectations for this role is limited and mainly flexible (<20%)

Location: 

• Home office is at Richmond, IL.  This is an onsite role but will be working with individuals globally.

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit.  This job description may be changed at any time.

The salary range for this role is between $120,000-$130,000. 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. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.
 

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and Retirement Benefits to eligible employees. 
 

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

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Join our winning team today. Together, we’ll 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. 

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.

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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.