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
- Minimum of 2 years related experience from Medical Device or Biomedical industry, with a university degree in Biomedical/ Mechanical/ Electrical/ Robotic Engineering, or equivalent
- Proven experience in investigating issues, driving creative problem solving related to product/process issues and effectively documenting as needed
- Strong understanding of quality records requirements and documentation
- Experience collaborating effectively with product and/or process subject matter experts in a cross-functional team environment
- Experience navigating multiple activities with changing priorities. Ability to execute to required timelines
- Proficient verbal and written communication in English
Preferred Skills and Experience
- Experience with root cause analysis and problem solving or analytical troubleshooting methods (e.g., 5 Whys, Fishbone diagram, Is/Is Not Diagram, fault trees, etc.)
- Experience in Quality, Engineering, Operations, or a continuous improvement environment
- Knowledge of Quality Systems Regulations (21 CFR 820) and ISO 13485
- Experience in problem solving, technical savvy with complex electro-mechanical devices, proficient technical writing ability and passion for the best practices to analyze, monitor, and improve both product and process
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
