Stryker is hiring a Senior Software Quality Engineer, Post Market to support its Medical’s Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) to support projects as a quality engineer for post-market activities to drive customer quality.
Requirements
- Experience with Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), supporting post-market activities to ensure compliance, drive customer quality, and address regulatory requirements, with proficiency in Salesforce, SAP, TrackWise, Jira, Windchill, Atlassian Suite, Zendesk, and ServiceNow.
- Experience in software technical support resolution, ensuring compliance with industry standards in handling Non-Conformances and Corrective Action and Preventative Action (NC/CAPA).
- Extensive experience within the medical device industry, ensuring compliance with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304, including handling Non-Conformances and Corrective Action and Preventative Action (NC/CAPA).
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.
- Work on cybersecurity monitoring and data privacy related responses with Legal/Compliance/Product Security teams.
Other
- 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.
- Bachelor’s degree in science or engineering.
- Travel Percentage: 20%
