LifeWave Corporate · 17 hours ago
Director of Quality
Draper, UT
Full-time
Onsite
Director/Executive
8+ years expLifeWave Corporate is seeking a strategic and experienced Quality Director to lead their Quality Management System (QMS) and ensure compliance with ISO standards. The role involves overseeing quality policies, managing teams, and maintaining product integrity in a medical device environment.
Health Wellness & Fitness
Hiring Manager
Cristina T.
Responsibilities
Lead and manage the Quality Assurance and Quality Control teams
Define quality objectives and drive a culture of continuous improvement
Act as the Management Representative for ISO certifications and audits
Oversee and maintain the QMS to ensure compliance with ISO 9001:2015 and ISO 13485:2016
Manage document control, change control, CAPA, internal audits, non-conformance reporting, and risk management processes
Ensure alignment of Quality Management Systems with applicable regulatory requirements (e.g., FDA)
Plan and lead internal and external audits, including third-party certification and regulatory inspections
Respond to audit findings and ensure timely implementation of corrective actions
Establish and maintain supplier quality management programs
Conduct supplier audits and monitor supplier performance metrics
Collaborate with the training department to develop and deliver quality training programs across the business unit
Ensure employees are trained and compliant with relevant quality procedures
Qualification
Required
Bachelor's degree in engineering, Life Sciences, Quality Management, or related field
Minimum of 8–10 years of experience in quality assurance/control in a regulated industry (medical device, pharmaceutical, or manufacturing)
Strong expertise in ISO 9001 and ISO 13485 standards
Proven experience managing audits and maintaining quality certifications
Strong leadership, communication, and project management skills
Preferred
Master's degree
Knowledge in the cosmetic industry
Company
LifeWave Corporate
Driven by innovation and proven by science, LifeWave is a breakthrough patented health technology company dedicated to honoring the light of life and harnessing the body’s natural energy to reverse aging and maximize human potential, while holding true to its values of high product standards, leading with service, being socially responsible, and striving to make a difference through unprecedented humanitarian advancement.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Aerin Lofton
Brand Partner
Jayme Knight
Optimal Health Advocate I Independent Brand Partner
Company data provided by crunchbase