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 **Quality System Specialist** for our **Medical Division** in **Kalamazoo, MI** where you will be an integral part of the diverse and dynamic Quality Systems team. This role will support various quality management system (QMS) processes like Training, QMS Document Change Management, Record Retention, and Internal Quality Agreements. This involves working closely with the Site Process Owners (SPO) for these processes to sustain the day-to-day activities, drive engagement and continuous improvements. **Work Flexibility:** Hybrid; Candidate must reside within a commutable distance to Kalamazoo, Michigan but is expected to be onsite at the facility at least 3 days/week (Monday, Tuesday & Wednesday) with optional remote flexibility on Thursday and Fridays. This is based on the business need at the time. **What you will do:** + Assist subject matter experts, document owners, and process owners to support document change orders including initiating, launching, tracking, and implementing in PLM systems. + Support/assist the record retention process, including relationship with 3rd party document storage facility through document storage/retrieval and ensure invoicing accuracy + Support creation, approval, and management of internal quality agreements including periodic reviews, updates, and approvals + Monitor training assignments and metrics for process compliance. + Serve as the Stryker Learning Management System (SLMS) expert to address stakeholder training requests. + Support process owners to ensure QMS processes align with FDA, ISO, and various international standards and regulations. + Drive continuous improvement initiatives through audit findings and compliance gaps. + Maintain a state of audit readiness (prep and ongoing compliance). **What you need:** Required: + Bachelor’s degree or higher with no prior work experience necessary. Preferred: + ​1–2 years of experience in a regulated industry within a Regulatory Affairs, Quality Assurance, or Quality Control role, with demonstrated proficiency in adhering to QMS processes. + Must possess high level knowledge of MS Office applications + Basic knowledge of quality management systems as it relates to FDA, ISO 13485:2016, MDSAP, and other international regulations 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.