Quality Management System Lead

About the role

At Cytiva, 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. 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. 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. It is an on-site role.

Responsibilities

• Lead and manage customer audit program by coordinating and hosting audits, maintaining site-wide audit readiness, and managing the 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.

Requirements

• 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.

Skills

• 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.

Benefits

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Benefits include:

• Paid time off.
• Medical, dental, and vision insurance.
• 401(k) retirement plan.

This role is also eligible for bonus/incentive pay.