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.
Travel Percentage: 10%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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.