Manager, Quality Assurance
Manager, Quality Assurance
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Salary Not Disclosed
1 Vacancy
Job Description
Stryker is hiring aManager Quality AssurancesupportingGlobal 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
Bachelors 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
Required Experience:
Manager
Employment Type
Full-Time
