We are seeking a **Senior Manager, QMS,** in **Portage** , **Michigan** to lead the Global Quality Operations (GQO) function for our **Medical Division** ! You will drive strategic, compliance, and business objectives within the Quality Management System (QMS) while supporting the Franchise Quality Leader (FQL) and Divisional Manufacturing Leader (DML). You will lead teams focused on **Nonconformance (NC), Corrective and Preventive Actions (CAPA),** and **QMS activities** , ensuring consistent, compliant, and efficient operations. Additionally, you will collaborate cross-functionally to uphold product quality and ensure alignment with industry standards and regulatory requirements. **What You Will Do:** **Leadership:** + Fosters a positive, inclusive team culture through open communication, engagement, and development. + Sets strategic direction for Quality Systems teams to deliver strong service and business support. + Drives talent strategy and collaboration; builds trust and develops team capabilities across the franchise. **Regulatory Compliance & Auditing:** + Coordinate and manage external audits and ensure timely responses to audit findings. + Maintains an up-to-date Quality Management System aligned with evolving regulations, standards, and policies. **NC and CAPA Management:** + Oversee NC and CAPA systems to ensure timely containment, thorough investigations, and effective corrective actions. + Utilizes data analysis to identify adverse trends and ensures root cause analysis and effectiveness checks are completed. ​ **Training & Development:** + Develops and delivers strategic training on quality systems, regulations, and QMS processes across all levels. + Mentors and develops the Quality team to build capability and performance. + Promotes a strong quality culture through ongoing education and communication. **Continuous Improvement:** + Drives continuous improvement and harmonization of Quality Systems across GQO, focusing on standardizing work and optimizing resources for efficiency. + Designs and coordinates governance structures and communication platforms for QS strategic initiatives. + Develop strategic roadmaps for key QS functions, including NC/CAPA, Change Control, Document Control, and QMS **Cross-functional Collaboration:** + Influence across the organization by building effective relationships with key stakeholders across divisional functions, QS, QA, Corporate, NPI, and M&A to drive collaboration. + Partners with Franchise Quality Leader and divisional QMS leaders to develop and deploy Quality Systems strategy. **What You Need:** **Required** + Bachelor’s degree required. Preferred to be in engineering, sciences, or related fields. + 10+ years of experience in quality assurance, quality systems management, or closely related. + Experience in a regulated industry. + 3+ years in a leadership role overseeing quality systems and NC/CAPA. **Preferred:** + In-depth knowledge of regulatory standards, including ISO 13485, FDA 21 CFR Part 820, ISO 14971, and EU MDR. + Proven experience in leading audits (internal, external, regulatory). + Excellent analytical and problem-solving skills, with a strong focus on data-driven decision-making. + Familiarity with quality management software (e.g., onePLM, **TrackWise** , etc.). 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.