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 Manager, Quality Assurance and Quality Control for Leica Biosystems Richmond is responsible for providing leadership and support of daily quality operations including QC finished goods and raw material inspection program, QA product release, nonconformance workflows, CDT&R, and calibration.
This position reports to the Director, Quality Assurance and Regulatory Compliance responsible for ensuring that the business, product, and processes meet all Quality and Regulatory standards and requirements. This position is part of the Quality Assurance and Regulatory Compliance department located in Richmond, Illinois and will be onsite.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Bachelor’s degree or equivalent advanced degree in engineering, science, medical, or technical field and 5+ years’ experience with increasing responsibility in medical device/IVD
• Experience working within a medical device quality system in compliance with US FDA, ISO 13485 and EU MDR/IVDR regulations
• Proven experience in developing and implementing mining tools to monitor product complaint trends including defined control and/or action limits to detect emerging field issues
• Track record of collaborating with technical groups to identify product improvement opportunities

TRAVEL, MOTOR VEHICLE RECORD & PHYSICAL/ENVIRONMENT REQUIREMENTS:

• Travel requirements < 5% of the time, domestic and international
• Overnight travel may be required
• Be able to occasionally lift and/or move up to 40 pounds.
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• This position will occasionally require travel by car and flying in and out of airports with possible long wait times

IT WOULD BE A PLUS IF YOU ALSO POSSESS PREVIOUS EXPERIENCE IN:

• Knowledge of lean tools such as 5S, Standard Work, KANBAN, Policy Deployment, Value Stream Management, Visual Management, SAP etc.
• Demonstrated knowledge of Quality Management Systems, continuous improvement methodologies, and understanding of manufacturing processes with high mix low volume and high mix high volume environment.
• Demonstrated ability to lead, develop, communicate, and implement a strategy to ensure compliance to company, regulatory and industry requirements.
• Experience and/or knowledge of NCRs
  The annual salary range for this role is $120,000 - $140,000. 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 comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) 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.

• Hire, develop, engage, and retain highly capable QA and QC team members, ensuring that each associate is meeting performance requirements and that each critical position has an identified successor with a targeted and robust development plan.
• Oversee inspection and product release activities as well as CDT&R, and develop key strategies to support future business success.
• Coach the team on how to effectively manage and anticipate changing needs for resources and how to flex resource allocation in the face of changing circumstances, including notifying stakeholders and recommending countermeasures to ensure that cross-functional teams and projects are staffed with qualified and skilled QA and QC associates and business needs are met.
• Manage relationships with relevant cross-functional leaders including participating in Daily Management meetings and effectively communicating issues, risks, and needs to the Leadership team.
• Plan, prioritize, and coordinate workflow and cross-site/function interactions to ensure on time delivery of product and projects and compliance with quality systems and standards, using advanced knowledge of Danaher Business System (DBS) tools.
• Ensure site audit readiness at all times through monitoring and learning from past audits, training and preparation of staff and mitigation of risks.
• Support team in formulating and testing effective data-based strategy for winning against the competition or exceeding expectations as a team.