Quality Assurance Specialist

hace 2 meses


Mexicali, Baja California, México Intuitive Surgical A tiempo completo
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Intuitive Surgical. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our medical devices.

Key Responsibilities
  • Quality Advocacy and Project Management
    • Develop and apply corporate level quality metrics to drive improvement and compliance.
    • Lead and project manage quality initiatives in areas such as product quality, data quality, and process quality.
  • Design and Manufacturing Support
    • Support design and manufacturing projects to ensure quality and compliance.
    • Collaborate with cross-functional teams to identify and implement quality improvements.
  • Failure Analysis and Root Cause Investigation
    • Analyze returned products to identify root causes of failures.
    • Develop and implement methods and procedures for disposition of discrepant material.
  • Quality Control and Assurance
    • Develop and implement quality control and assurance procedures to ensure compliance with regulatory requirements.
    • Review and interpret complex data analysis to inform quality decisions.
Requirements
  • Minimum 5 years of related experience with a University degree; or 3 years' experience and a Master's degree; or a PhD; or equivalent experience.
  • Minimum 4+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 2 years in medical device design or manufacturing environment.
  • Strong understanding of quality and compliance systems, including CFR 21 820 and ISO 13485.
  • Excellent analytical and problem-solving skills, with ability to learn and adapt quickly.
  • Strong communication and collaboration skills, with ability to work effectively in cross-functional teams.
Preferred Qualifications
  • Able to cope with changes and uncertainties, and handle associate risks comfortably.
  • Driven by results, with ability to prioritize and manage time effectively.
  • Strong leadership and project management skills, with ability to lead and motivate teams.
About Intuitive Surgical

Intuitive Surgical is an equal opportunity employer, committed to diversity and inclusion. We prohibit any form of discrimination and harassment, and provide equal opportunities to all qualified applicants and employees, regardless of race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran status, or disability.



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