Post Market Surveillance Quality Engineer

Intuitive Surgical

Bangalore, Karnataka
Permanent
Full-time

16 days ago

Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.Job DescriptionPrimary Function of the PositionThe 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

Qualifications

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

Additional InformationIntuitive 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.

Intuitive Surgical

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