The Quality Management System (QMS) Lead is responsible for maintaining, improving, and ensuring compliance of the site's Quality Management System. This role is critical to supporting ongoing operations at the Logan site, including managing the customer audit program and schedule, ensuring regulatory compliance, and enabling continued growth and expansion. The QMS Lead is accountable for maintaining the site's ISO 9001 and 13485 certifications, ensuring continued alignment with applicable standards and readiness for external surveillance and recertification audits. This position coordinates closely with corporate quality teams to support corporate audit activities, ensuring site alignment with enterprise quality strategies and requirements. In addition, the QMS Lead oversees and supports site documentation within the electronic Quality Management System (eQMS), ensuring documents are accurate, controlled, and compliant with internal and external requirements. This position reports to the Senior Manager, Quality Assurance and is part of the Quality Assurance department located in Logan, Utah and will be an on-site role. What you will do: - Lead and manage customer audit program by coordinating and hosting audits, maintaining site-wide audit readiness, and manage audit schedule. - Maintain and continuously improve the site Quality Management System (QMS), ensuring compliance with ISO 9001 and ISO 13485 standards and supporting successful surveillance and recertification audits. - Provide quality guidance and leadership across the site by ensuring documentation accuracy, completeness, and adherence to Good Documentation Practices within the eQMS, while partnering with cross-functional teams to maintain system integrity. - Coordinate corporate audit support and drive internal audit activities, including Quality Walks and coaching, ensuring timely closure of findings, effective CAPA implementation, and alignment with enterprise quality expectations. Who you are: - Bachelor's or Master's degree from an accredited institution. - Demonstrated understanding or aptitude to understand regulatory requirements including FDA 21 CFR 820, ISO 13485, and ISO 9001. - Communication & Problem Solving: Proven ability to manage competing priorities in fast-paced settings; skilled in technical writing, stakeholder communication, and facilitating collaborative problem-solving with attention to detail and quality. Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. 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.