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

　　Quality System Specialist (Hybrid)

　　Portage, MI

　　Stryker is hiring a Quality System Specialist in Portage, MI. As a Quality System Specialist, you will be an integral part of the diverse and dynamic regulatory and quality department at the Stryker Medical Division in Kalamazoo, Michigan. You will partner with existing system/process experts to learn and grow while helping execute and maintain them to achieve compliance and efficiency. This may include supporting or leading the processes for QMS Change Control, Internal Audit, Training, Record Retention, NC/CAPA, Internal Quality Agreements, or other QMS supporting processes. This role will interact with all areas of our business to drive regulatory compliance of our processes while innovating and driving actions to generate engagement and continuous improvement of the processes.

　　Who we want:

　　Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate. Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

　　What you will do:

　　Partner with subject matter experts and process owners to support document change orders including initiating, launching, tracking, and implementing in PLM systems.Work with the Corporate document control office to communicate upcoming changes to subject matter experts (SMEs) and process owners in the division/site.Support the NC/CAPA process owner as NC/CAPA Specialist (review/approvals) and process management and monitoring.May manage/lead the record retention process and act as liaison between Stryker and the 3rd party document storage facility.Drive continuous improvements of the processes you are involved in to increase efficiency and engagement within the organization.Manage quality system procedures tied to your processes through monitoring and updates, as necessary.Manage/lead quality projects/initiatives that helps us achieve our strategic vision and key initiatives.Participate in internal/external audits of our Quality Management System as you develop into a subject matter expert of your processes.Support process owners and SMEs within the organization to maintain their respective processes effectively and compliantly.May conduct training of various teams or individuals within the organization.May support other quality systems processes as directed by management.

　　What you need:

　　Required qualifications:

　　Bachelor's Degree in engineering, science, business, or related discipline.

　　Preferred qualifications:

　　Work experience in a regulated industryBasic knowledge of quality management systems as it related to FDA, ISO, and other international regulations.Strong communication, project management and influencing skills.Ability to plan, organize, and implement multiple concurrent tasks.Strong interpersonal, technical writing, oral communication, and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.Demonstrated ability to work in cross-functional team environments.Builds strong relationships by fostering open communication, respect, and trust.Act with a customer service/stakeholder-focused approach.

　　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.