Stryker is looking to solve the problem of ensuring compliance with Quality Management System requirements for post-market activities of medical and non-medical device software, driving customer quality and continuous improvement.
Requirements
- Working knowledge of QA practices, including defect tracking and risk-based testing, especially in post-market or production environments involving NC/CAPA processes.
- Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.
- Knowledge of software development life cycle (SDLC), software validation, and agile methodologies.
- Hands-on experience using Power BI or similar tools for basic data visualization and monitoring.
- Exposure to Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), or Software as a Non-Medical Device (SaND), with a general understanding of FDA guidance on software classification.
- Experience with software industry practices, compliance standards and guidance (FDA/HHS).
- Knowledge of cybersecurity and data privacy principles and practices.
Responsibilities
- 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 software solution 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.
- Support cybersecurity and data privacy efforts in collaboration with Legal, Compliance, and Product Security teams, addressing monitoring activities and regulatory responses.
Other
- Bachelor’s degree in science or engineering.
- Minimum of 4 years of experience as an Engineer.
- Travel Percentage: 20%
- Ability to commute to one of the specific facilities (San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN) as needed.
- Strong collaboration and communication skills.
