Staff Software Quality Engineer, Post Market
: Job Details :

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/ Zen. Desk/ 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 collaborat...Quality Engineer, Software, Technical Support, Staff, Quality, Engineer, Manufacturing