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 initiatives—all 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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.