Post Market Surveillance Quality Assurance Specialist
3 weeks ago
At Intuitive Surgical, we are driven by a shared vision to revolutionize minimally invasive care. Our team is united behind a mission to empower physicians to heal without constraints, leveraging intelligent technology and ingenuity to advance the possibilities of healthcare.
Job SummaryThe Post Market Surveillance Quality Assurance Specialist will play a critical role in ensuring the safety and effectiveness of our products, collaborating with cross-functional teams to identify, investigate, and resolve issues. This position requires a strong understanding of quality systems regulations and a passion for driving continuous improvement.
Key Responsibilities- Collect and analyze data from various sources to inform root cause investigations and ensure compliance with regulatory requirements
- Collaborate with internal teams to develop and implement effective solutions to product and process issues
- Serve as a subject matter expert for Post Market Surveillance and Quality internal and external audits
- Manage assigned complaint investigation workload to meet operational goals
- Execute Quality Systems and Post Market Surveillance projects
- Minimum of 2 years related experience from the 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, 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 and executing to required timelines
- Proficient verbal and written communication in English
- Experience with root cause analysis and problem-solving or analytical troubleshooting methods
- 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 best practices to analyze, monitor, and improve both product and process
Intuitive Surgical 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.
Shift: Day
Travel: 10% of the time
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Bengaluru, Karnataka, India Intuitive Surgical Full timeCompany OverviewAt Intuitive Surgical, we are driven by a shared vision to revolutionize minimally invasive care. Our team is united behind a mission to empower physicians to heal without constraints, leveraging intelligent technology and ingenuity to expand the possibilities of healthcare.We are a pioneer and market leader in robotic-assisted surgery,...
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