Staff Quality 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 **Staff Quality Engineer** to support our Medical’s Digital Health division and portfolio (Software as a Medical Device/Telehealth) to support projects as a quality engineer for post-market activities to drive customer quality. You will execute Digital Health (Software as a Medical Device/Telehealth) projects as a quality engineer for post-market activities to drive customer quality. **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:** + Collaboratively ensure compliance with Quality Management System requirements for post-market activities, driving NC, CAPA, and PFA processes in partnership with the business. + Partner with the Professional Services and Technical Support Organization to ensure quality customer outcomes through installation and tech support activities and processes. + Drive and complete complaint investigations including follow up with customers and internal cross functional stakeholders while using enterprise tools (SalesForce/SAP/Trackwise/Jira/Windchill/Atlassian Suite/ZenDesk/ServiceNow). + Conduct risk assessments and Health Hazard Analysis as required in conjunction with R&D and Quality. + Work on process improvement projects while applying software industry practices, compliance standards and guidance (FDA/HHS). + Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures. + Ensure cybersecurity and data privacy regulations are met in the post market space. + Oversee and track post-market KPIs for MDR, business reviews, and continuous process improvement, providing data analytics, KPI insights, and project status updates in business and management reviews. **What you need:** **Required:** + Bachelor’s degree in science or an engineering discipline. + Minimum of 4+ years of experience in a regulated industry, preferably within the medical device sector, in areas such as R&D, Quality, or Regulatory Affairs + Demonstrated knowledge and experience working through software lifecycle processes (Agile SAFe/Waterfall). **Preferred:** + Demonstrated applied knowledge of software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and Risk assessments. + Demonstrated experience participating in both internal and external audits. + Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required. + Demonstrated experience using salesForce/SAP/Trackwise/Jira/Windchill/Atlassian Suite/ZenDesk/ServiceNow preferred. $85,500.00 to $182,100.00 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.