Post Market Surveillance Supervisor - Bengaluru, India - Intuitive Surgical

Intuitive Surgical Bengaluru, India

3 weeks ago

Employee

Description

Company Description

At 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 Description

Leadership:

Provide day-to-day supervision of the activities conducted by the India Quality Engineering complaint investigation team including approval of timecards and time off requests
Conduct 1:1 and performance review meetings and responsible for PMS team training and development.
Manage complaint workload for direct reports to achieve required goals
Participate and ensure completeness of new hire training and continuous Regulatory Compliance training as required.
Maintain accurate records and operational metrics of post-market surveillance activities and ensure compliance with regulatory requirements

Technical:

Ensure a rigorous root cause and complaint investigation is completed and documented.
Ensure completeness, accuracy, and consistency of complaint documentation and provide feedback to team members where necessary.
Approve complaint investigation file after all applicable actions are completed.
Provide direction and feedback to ensure compliance to Intuitive processes and procedures.
Lead process improvement activities to continuously improve process effectiveness
Serve as SME and on-site lead for PMS and Quality internal and external audits.

Qualifications

Minimum of 5 years related work experience with a university degree; or equivalent experience
3+ years in employee management experience (e.g. Supervisory/Lead role or equivalent- in a Medical Device, Biomedical, Aerospace engineering or similar highly regulated company.
Strong understanding of worldwide regulatory requirements for medical devices, including post market surveillance, complaint handling, CAPA, Field Actions.
Proven ability to conduct root cause analysis and problem-solving techniques related to product/process issues and effectively document as needed
Experience with Medical Device Complaint files and quality record documentation
Strong experience and knowledge of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
Strong computer skills (Excel, Word, PowerPoint, database)
Proficient verbal and written communication in English,
Project management skills preferred.
Ability to interface cross-functionally with other groups and build productive working relationships with all stakeholders

Additional Information

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.