Post Market Quality Assurance Specialist

4 weeks ago


Bengaluru, Karnataka, India Intuitive Surgical Full time
Post Market Quality Assurance Role

The Post Market team at Intuitive Surgical plays a vital role in ensuring the safety and effectiveness of our products. This team collaborates across the organization to understand product and process performance, identify areas for improvement, and implement solutions. Key functions include Post Market Surveillance, Field Action, Data Analytics, Clinical Engineering, Field Service, Technical Support, Customer Service, Risk Management, Service Operations, and Failure Analysis Engineering.

Responsibilities:

  • Collect and analyze data from various sources, including complaint files, risk management documentation, and CAPA files, to identify opportunities for improvement.
  • Ensure investigation documentation is complete and consistent to meet regulatory requirements.
  • Collaborate with internal teams, such as Advanced Failure Analysis Engineering and Clinical Development, as needed.
  • Provide subject matter expertise and lead on-site audits for Post Market and Quality internal and external audits.
  • Implement Quality System and Post Market Surveillance projects, and manage assigned complaint investigation workload to meet operational goals.

Qualifications:

  • Minimum of 2 years of experience in the Medical Device or Biomedical industry, with a university degree in Biomedical, Mechanical, Electrical, or Robotic Engineering, or equivalent.
  • Proven experience in investigating issues, driving problem-solving, and documenting findings.
  • Strong understanding of quality records requirements and documentation.
  • Experience collaborating with product and process subject matter experts in a cross-functional team environment.
  • Ability to navigate multiple activities with changing priorities and execute to required timelines.
  • Proficient verbal and written communication in English.

Preferred Skills:

  • Experience with root cause analysis and problem-solving methods, such as 5 Whys and Fishbone diagrams.
  • Knowledge of Quality Systems Regulations (21 CFR 820) and ISO 13485.
  • Experience in problem-solving, technical savvy with complex electro-mechanical devices, and proficient technical writing ability.
Intuitive Surgical

We are an Equal Employment Opportunity Employer, committed to providing equal employment opportunities to all qualified applicants and employees, 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.



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