**Staff Specialist, Quality Management Systems** _Portage, MI_ Stryker is seeking a **Staff Specialist, Quality Management Systems** to lead the development and maintenance of our Quality Management System (QMS) in compliance with global medical device regulations. This role ensures the QMS is effective, efficient, and audit-ready, supporting regulatory clearance and certification efforts. **Work Flexibility:** _Hybrid_ : Candidates must reside within a commutable distance to Portage, MI, and be able to work onsite several times per week. **What you will do:** + Serve as the Instruments Division Process Owner for internal and external audits, managing logistics, tools, and training. + Maintain and improve QMS documentation related to audit processes and represent the division during audits. + Act as the liaison between the Global Process Owner and the division to implement QMS initiatives and improvements. + Manage QMS documentation requests in onePLM, including creating and tracking change requests. + Prioritize and ensure timely completion of documentation tasks based on internal and external deadlines. + Lead gap assessments for regulations and standards (e.g., ISO 13485) and drive remediation efforts. + Oversee implementation of corporate requirements and Managed Release reviews across the Instruments Division. + Support cross-functional teams as the voice of Quality, contributing to strategy and continuous improvement. **What you need:** Basic Qualifications: + Bachelor’s degree.​ + 4+ years of experience in Quality Systems (e.g., CAPA, audits, Management Review, Quality Planning) Preferred Qualifications: + PMP certification or strong project management experience. + Familiarity with Windchill and TrackWise systems + Knowledge of U.S. and international medical device regulations + Ability to lead complex strategy and project execution at several sites and determine/implement processes for introduction of new sites. + Strong stakeholder engagement and customer service mindset 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.