Why RA/QA at Stryker?

　　Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !

　　Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

　　We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

　　Stryker is hiring a Senior QMS Specialist for our Instruments division in Portage, MI. This person will offer support to the organization with knowledge, application and understanding of the regulatory and legal framework, regulatory requirements, legislation, process and procedures.

　　Who we want-

　　Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business.

　　What you will do:

　　Develop, modify, and execute process guidelines, procedures, and document author responsibilities in the PLM system.Support diverse business tasks, including audits, M&A activities, system reviews, and EUMDR activities.Lead continuous improvement in the Project Management Office for enhanced transparency in New Product Development.Run the Policy Review Board for new standards and gap assessment metrics.Implement and maintain standards for new product and post-market development in the PLM system.Research, analyze, and communicate interpretations of regulations and standards.Serve as Divisional Process Owner for Standards and Regulation Management, overseeing audits for multiple Instruments sites.Collaborate for process improvement with Corporate program and cross-divisional contacts.Manage user training and access for the standards management system.Lead broad and complex internal projects.

　　What you will need

　　Required:

　　Bachelors degree is requiredA minimum of 2 years of proven success in roles within a regulated industry, demonstrating comprehensive understanding and adherence to regulatory guidelines and compliance standards.

　　Preferred

　　Experience in the Medical Device Industry.Must possess strong communication, project management, and influencing skills as well as successfully manage multiple tasks simultaneously.Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.

　　About Stryker

　　Our benefits:

　　12 paid holidays annually Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

　　For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

　　About Stryker

　　Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.

　　Know someone at Stryker?

　　Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page

　　Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.