We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) **Stryker** is hiring a **Specialist, Post Market Quality** in **Portage, MI** supporting **Instruments** ! In this role, you will support to the Post-Market Quality team that is responsible for both domestic and international complaint handling along with the product field action team. Specifically, this position is responsible for the coordination of material and information to meet quality and regulatory requirements. **Work Flexibility:** Hybrid. This role requires reasonable proximity to our Stryker facility in Portage, MI. You should be comfortable working 3-days onsite. **What you will do** + Participation in product field action strategy meetings. + Creation and mailing of customer letters for product field action notification. + Communicate directly with customers to perform product field action effectiveness checks on open actions. + Coordination with customer care teams on replacement products and credits. + Communicate with internal and external resources globally on product field action execution activities. + Provide updates within Trackwise on status of product field action executions. + Monitor and facilitate product return for complaint investigation and analysis, including communicating directly with customers and sales teams. + Provide updates within Trackwise on status of event detail information and product returns to support complaint handling activities. + Work with internal and external partners on the facilitation of movement of complaint return product. + May support international and domestic complaint entry. + Support management with various weekly, monthly and quarterly reporting as needed. + Work with internal supporting teams on quality of data coming into post market. + May monitor, create and assign regulatory communications to quality specialists for resolution. + Involvement in team projects as requested. **What you need** **Required:** + Bachelor’s Degree or higher with no prior work experience necessary. **Preferred:** + Bachelors degree or higher in Regulatory Science, Engineering, Science related discipline. + Regulatory Affairs Certification (RAC) preferred. + Proven experience in regulated industries, with a strong preference for the medical device sector. + Expertise in post-market quality processes, including complaint handling and product field action process as required by regulatory agencies. 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. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. 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.