Quality Engineer, Rack Infrastructure – Site Operations
OpenAI
PMP
Staff Software Quality Engineer, Post Market
Stryker
full-time
Posted on:
Location: California, Florida • 🇺🇸 United States
Visit company websiteSalary
💰 $87,600 - $186,700 per year
Job Level
Lead
Tech Stack
CloudCyber SecuritySDLCServiceNow
About the role
- 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.
- 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.
- Develop and implement a QMS for non-medical devices to ensure product quality, efficient processes, and compliance with industry standards (e.g., ISO 9001).
Requirements
- Bachelor’s degree in science or engineering.
- Minimum of 4 years of experience working in the areas of Research & Development (R&D), Quality (QA/QC), Information Technology, Healthcare IT, Regulatory Affairs (RA) or Technology industry.
- Experience in software technical support resolution ensuring compliance with industry standards in handling Non-Conformances and Corrective Action and Preventative Action (NC/CAPA).
- 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.
- Preferred: Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills.
- Experience in software technical support resolution 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).
- Experience with digital health platforms, cloud infrastructure, and/or cybersecurity.
- Experience with SaMD, SiMD, and non-medical device software post-market activities to ensure compliance and quality, proficient in Salesforce, SAP, TrackWise, Jira, and related tools.
- Excellent communication, documentation, and cross-functional collaboration skills.
