Manager, Quality Assurance

Manager, Quality Assurance

Stryker is hiring a Manager, Quality Assurance supporting Global Quality Business Operations. This is an onsite role based in Salt Lake City, UT.

As Manager, Quality Assurance, you will lead a high-performing team dedicated to ensuring our products meet the highest standards of safety, compliance, and performance. This is a strategic leadership role where your impact will be felt across operations, regulatory audits, and global quality initiativesall in support of life-saving neurovascular technologies.

What You Will Do

• Lead a team of quality professionals, providing technical guidance and fostering a culture of continuous improvement and collaboration.
• Ensure site-wide compliance with regulatory standards including ISO 13485, MDR, and FDA QSR, and maintain certification with all relevant bodies.
• Manage internal and external audits, acting as deputy Management Representative in the absence of the site head of Quality.
• Drive resolution of product and process deviations, including supplier-related issues, and oversee implementation of effective corrective actions.
• Develop and execute a pipeline of quality improvement initiatives focused on product quality, risk management, and operational efficiency.
• Monitor Quality KPIs and business metrics, taking timely action to address adverse trends and support strategic planning.
• Collaborate globally by leading cross-functional and cross-site process improvement initiatives and benchmarking best-in-class practices.
• Support talent development through effective training, performance management, and succession planning for the quality team.

What You Need

Required

• Bachelor's degree in engineering, quality assurance, or related scientific discipline
• Minimum 8 years of experience in an FDA regulated industry (medical device, pharmaceutical, etc.)
• Minimum 2 years of management experience

Preferred

• Experience with quality tools, methodologies, and project management systems (e.g., Microsoft Project)
• Demonstrated auditing experience in medical device or regulated manufacturing environments
• Applied understanding of 21 CFR 820, ISO 13485, MDR, and other applicable regulations
• Experience developing quality management systems, training programs, and lean documentation
• Certification or coursework in Six Sigma, ASQ-CQE, or CQA

Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.