Post Market Surveillance Quality Assurance Specialist
4 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 expand the possibilities of healthcare.
We are a pioneer and market leader in robotic-assisted surgery, committed to fostering an inclusive and diverse team that is passionate about making a difference. With over 25 years of experience, we have worked with hospitals and care teams worldwide to address some of healthcare's most pressing challenges and advance what is possible.
Our culture is built on the principles of diversity of thought, mutual respect, and a commitment to excellence. We believe that great ideas can come from anywhere and strive to create an environment where our team members can thrive and grow.
Job SummaryThe Post Market Surveillance Quality Assurance Specialist will play a critical role in ensuring the safety and effectiveness of our products and processes. This position will collaborate with cross-functional teams to investigate and resolve issues, drive quality improvements, and ensure compliance with regulatory requirements.
The ideal candidate will have a strong understanding of quality systems, regulatory requirements, and analytical troubleshooting methods. They will be able to effectively communicate with stakeholders, navigate complex issues, and execute to required timelines.
Key Responsibilities- Investigate and resolve product and process issues through root cause analysis and problem-solving
- Collaborate with cross-functional teams to drive quality improvements and ensure compliance with regulatory requirements
- Develop and implement effective solutions to address quality and compliance issues
- Communicate complex information to stakeholders, including technical writing and presentation skills
- Manage and prioritize multiple activities with changing priorities, ensuring timely execution
- Minimum of 2 years of experience in a quality or engineering role, preferably in the medical device industry
- Strong understanding of quality systems, regulatory requirements, and analytical troubleshooting methods
- Excellent communication and problem-solving skills, with the ability to navigate complex issues
- Ability to work effectively in a cross-functional team environment, with a strong focus on collaboration and communication
- Proficient in English, with the ability to communicate complex information to stakeholders
- Experience with root cause analysis and problem-solving or analytical troubleshooting methods
- Knowledge of Quality Systems Regulations (21 CFR 820) and ISO 13485
- Experience in a quality or engineering role, preferably in the medical device industry
- Strong technical writing and presentation skills, with the ability to communicate complex information to stakeholders
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 advance the possibilities of healthcare.Job SummaryThe Post Market Surveillance Quality Assurance Specialist...
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