Senior Staff Quality Systems Engineer

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 **Senior Staff Quality Systems Engineer** to support our Medical’s Digital Health division and portfolio (Software as a Medical Device/Telehealth) to be responsible for defining and maintaining the quality management systems, processes, continuous improvement projects, project management and regulatory compliance for our digital health business.  **Workplace Flexibility & Location requirements:** This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed. Relocation assistance is approved for eligible candidates. **What you will do:** + Manage projects to establish direction for digital health business Quality Management Systems (QMS) and processes, enabling compliance and alignment with industry standards (IEC 62304/ISO 9001). + Collaborate with functional leaders (R&D, IT, Product Security, Regulatory, Privacy, Legal) to drive strategic decisions for the digital health business. + Develop and execute quality plans in partnership with business unit leaders, aiming to deliver measurable results. + Generate analytics reports and perform data analysis to support quality plans, including trending insights for decision-making. + Lead continuous improvement initiatives for QMS and business processes, tracking progress with defined KPIs. + Facilitate enterprise system support (e.g., Salesforce, SAP, Jira) to enable digital health operations in coordination with corporate and business units. + Partner with regulatory affairs to maintain compliance with standards across digital health, cybersecurity, and consumer regulations (FDA, HIPAA). + Present analytics, KPIs, and project updates to senior leadership and support global compliance audits (FDA, ISO, SOC II, Hitrust) while managing non-conformances and CAPAs. **What you need:** **Required:** + Bachelor’s degree in science or an engineering discipline. + Min 6+ years working in a regulated industry – preferable in medical device – (R&D, Quality or RA) + Demonstrated knowledge and experience working through software lifecycle processes (Agile SAFe/Waterfall). **Preferred:** + Demonstrated experience in the Medical Device and Technology Industry managing quality management systems. + Knowledge of software technologies for mobile, cloud and AI/ML solutions. (Amazon AWS/Microsoft Azure/Apple/Android etc.) preferred. 112,800.00 to 239,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors. 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.