Quality Management System Lead

Danaher•Logan, UT

15h•Onsite

About The Position

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.

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.
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.

Responsibilities

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.