We’re on the lookout for a data-driven Quality Manager to join our growing team. This position is responsible for providing organizational leadership for the overall quality management system and regulatory affairs in alignment with Katalyst’s mission, strategy, and organizational goals. The Quality Manager will oversee, create, and drive the vision and implementation of robust quality systems, including quality assurance of records, quality control, document control, process validation, supplier qualification, auditing, and nonconformance and occurrence management with CAPA and RCA. This position will collaborate with the Hardware, Software, and Executive Team as it relates to the organization’s quality improvement process and will ensure that quality systems data is collected and analyzed, and that quality goals are created and monitored for ongoing improvement in Katalyst’s pursuit of excellence.You’ll play a key role in Katalyst’s success transforming the health and fitness industry.
Founded in 2015, Katalyst is a groundbreaking, full-body Electro-Muscle Stimulation (EMS) workout that is designed to enhance your fitness at every stage of life. Our FDA-cleared EMS technology works with your body rather than against it, delivering personalized and efficient strength, power, cardio, and recovery workouts in just 20 minutes or less.
We’re ready to continue to build our small but mighty team. If you’re excited by innovative technology, enjoy solving problems in an agile environment, and are passionate about building a world class organization from the ground up, we want to hear from you! Learn more at www.katalyst.com.
- Own the functioning of the EQMS system
- Drive document completeness for both completed and ongoing projects
- Design Controls - Participate in hardware and software design meetings and collaborate with hardware and software teams to create lean processes and documentation creation that conforms to regulatory requirements
- Supplier Controls - Participate in supplier meetings and collaborate with supply chain to create lean processes and documentation creation that conforms to regulatory requirements
- Lead risk analysis and CAPA activities
- Complaint handling - Collaborate with Member Experience and create and manage lean and scalable processes for complaint handling
- Work with external compliance companies on an ongoing basis
- Organize and lead regular internal quality system and compliance audits
- Lead and represent the company in FDA audits