Lead Principal Specialist, Quality Assurance And Regulatory Compliance Service

Lead Principal Specialist, Quality Assurance And Regulatory Compliance Service

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.

The Lead Principal Specialist, Quality Assurance and Regulatory Compliance Service role will provide quality and 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 include:

• 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 and experience required include:

• 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 expectations for this role is limited and mainly flexible (<20%). Home office is at Richmond, IL. This is an onsite role but will be working with individuals globally.

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.