Principal Supplier Quality Engineer

Overview Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Microsystems, one of Danaher's 15+ operating companies, our work saves lives—and we're united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where your unique viewpoint matters. By harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Shape the Future with Us Leica Microsystems has been shaping the future for over 175 years with groundbreaking optical and digital solutions. Our culture is rooted in customer focus, innovation, and teamwork, leading the market in microscopy, imaging, and analysis. Joining Leica means contributing to scientific discoveries and supporting surgeons in making critical decisions. Our advanced microscopes and AI-based image analysis solutions enable users to gain profound insights into development and engineering challenges. Here, you will work on meaningful projects alongside passionate colleagues, driving progress and pushing the boundaries of what's possible. Learn about the Danaher Business System which makes everything possible. Responsibilities Supplier Qualification and Lifecycle Oversight Qualify and approve direct and indirect suppliers of critical components and special processes to ensure consistent, compliant output. Maintain supplier status through rigorous quality system assessments and performance monitoring. Evaluate and approve supplier-initiated changes to safeguard conformance with specifications, customer expectations, and regulatory standards. Conduct risk-based routine audits to verify adherence to contractual, customer, and regulatory requirements, driving sustained quality and reliability across the supply base. Supplier Issue Resolution and Continuous Improvement Lead on-site containment and resolution of complex nonconformances and escapes, applying structured problem-solving and implementing corrective and preventive actions. Exercise sound judgment using multiple data sources, operating with independence and accountability. Facilitate cross-functional teams to remove root causes and drive improvements in defect rate, rework, and on-time delivery. FAI/MRB Leadership, Audit Representation & Quality Reporting Lead and govern First Article Inspection (FAI) and Material Review Board (MRB) processes, ensuring timely execution and effective disposition of nonconforming material. Represent the team during external and third-party audits, addressing inquiries related to supplier management, FAI, and MRB. Establish and standardize inspection methods and measurement systems with suppliers. Provide clear reporting on supplier performance, quality trends, and systemic risks to management. Leadership and Technical Guidance Represent Supplier Quality Engineering in cross-functional forums, align initiatives with organizational goals, and mentor SQEs on quality practice and problem-solving. Govern critical quality activities, including engineering change impact/risk assessment, control plan reviews, customer complaint reviews, CAPA effectiveness, and inventory containment/traceability; ensure timely communication to suppliers and durable, long-term effectiveness of actions. Operational Excellence and Compliance Stay current with DBS tools to promote sustainable continuous improvement. Ensure departmental compliance with the Quality Management System and Environment, Health & Safety requirements, and address EHS concerns raised by associates. Qualifications Degree in a relevant Engineering discipline with 7 years of relevant experience or Diploma in a relevant Engineering discipline with 10 years of relevant experience. Experience in supplier quality engineering within an assembly operations or engineering environment. Strong knowledge of statistical control methods and QMS 9001. Familiar with ISO13485, US FDA QSR/cGMP (21 CFR Part 820) and ISO14971 for medical devices. Good understanding of metrology, inspection methods, equipment and engineering drawings. Knowledge of measurement techniques. Benefits and About Danaher Leica Microsystems, a Danaher operating company, offers a broad array of comprehensive benefits. Check out our benefits information. Join our winning team today. We'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to solve complex challenges, architecting solutions that bring the power of science to life. For more information, visit danaher.com. Danaher values diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and the markets we serve. Our associates contribute unique perspectives as a result of these diverse attributes. #J-18808-Ljbffr