Post Market Surveillance Quality Engineer

1 month ago

Bengaluru, Karnataka, India Intuitive Full time

About Intuitive

At Intuitive, we are driven by a shared passion for improving patient outcomes through innovative medical technology. Our mission is to empower healthcare professionals to deliver life-enhancing care with minimal invasiveness.

Job Summary

We are seeking a highly motivated and detail-oriented Post Market Surveillance Quality Engineer to join our team. As a key member of our Post Market team, you will play a critical role in ensuring the safety and effectiveness of our medical devices. Your primary responsibility will be to investigate and resolve issues related to our products, collaborating with cross-functional teams to drive quality improvements and compliance with regulatory requirements.

Key Responsibilities

  • Investigate and analyze data from various sources to identify and resolve product-related issues.
  • Collaborate with internal teams, including Advanced Failure Analysis Engineering, Clinical Development, and Software Engineering, to drive quality improvements and compliance.
  • Develop and implement effective root cause analysis and problem-solving methodologies to drive creative solutions.
  • Serve as a subject matter expert and on-site lead for Post Market Surveillance and Quality internal and external audits.
  • Manage assigned complaint investigation workload to meet operational goals and execute QS and PMS projects.

Requirements

  • Minimum of 2 years of related experience in 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.

Preferred Skills and Experience

  • Experience with root cause analysis and problem-solving methodologies, such as 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 best practices to analyze, monitor, and improve both product and process.

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.

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