Software Quality Engineer – Post Market
| Company | Stryker |
|---|---|
| Location | San Jose, CA, USA, Portage, MI, USA, Fort Wayne, IN, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level |
Requirements
- Bachelor’s degree in science or engineering.
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.
- 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.
Preferred Qualifications
- Experience working in the areas of Research & Development (R&D), Quality (QA/QC), Information Technology, Healthcare IT, Regulatory Affairs (RA) or Technology industry.
- Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills.
- 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). Additionally, 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).