Post Market Surveillance Quality Engineer
4 weeks ago
Primary Function of the Position
The Post Market team at Intuitive works at the intersection of Regulatory and Quality. The team engages across the organization to deeply understand how our products and processes perform, the implications of any issues, and support the execution of robust resolutions. Functions collaborating with the Post Market team include Post Market Surveillance, Field Action, Data Analytics, Clinical Engineering, Field Service, Technical Support, Customer Service, Risk Management, Service Operations, and Failure Analysis Engineering. The Post Market Team advocates for safety and effectiveness improvements by assessing field product performance and QMS processes to identify, investigate, communicate, and execute on opportunities.
Roles & Responsibilities:
- Collect and analyze data from ISI sources e.g., complaint file, risk management documentation, CAPA files, to ensure a rigorous root cause and complaint investigation is completed and documented
- Ensure completeness and consistency in investigation documentation to ensure compliance to requirements
- Collaborate with other internal teams (e.g., Advanced Failure Analysis Engineering, Clinical Development, Software Engineering, etc.) as needed
- Serve as SME and on-site lead for PMS and Quality internal and external audits
- Perform other duties as directed
- Manage assigned complaint investigation workload to meet required operational goals
- Execute QS and PMS projects and perform other duties as directed
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