Lead Principal Specialist, Quality Assurance and Regulatory Compliance Service

Danaher • Richmond, IL

153d

About The Position

At Leica Biosystems, a part of Danaher, we are dedicated to advancing cancer diagnostics and improving lives. Our mission drives us to innovate and provide reliable solutions that empower clinicians to deliver timely and accurate answers to patients. As a Lead Principal Specialist in Quality Assurance and Regulatory Compliance Service, you will play a crucial role in ensuring compliance with applicable regulations and standards across our global Selling Units (SUs). This position is based in Richmond, IL, where you will lead quality activities at our service and repair shop, acting as a key liaison between the SUs and Business Units (BUs). You will be part of a passionate team committed to making a real difference in the life sciences and biotechnology sectors.

Requirements

• Bachelor's degree in science, medical or technical field required.
• 7+ years' work experience with increasing responsibility in medical device/IVD Quality Assurance, demonstrating extensive knowledge of medical device quality systems including 21 CFR 820, MDSAP, ISO 14971, and ISO 13485.
• 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 the ability to work collaboratively with customers, cross-functional project teams, and regulators.

Nice To Haves

• Certifications in Quality Management, Quality Auditor, Lead Auditor, Six-Sigma Black Belt, Quality Engineer preferred.

Responsibilities

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree