Quality Assurance Engineer for Medical Devices

7 days ago


Hyderabad, Telangana, India Medtronic Full time

Medical Device Quality Assurance Role

We are seeking a qualified Quality Assurance Engineer to join our team at Medtronic.

About the Role

This is an exciting opportunity for a skilled quality assurance engineer to work on medical devices. As a Quality Assurance Engineer, you will be responsible for ensuring that our products meet the highest standards of quality and safety.

Main Responsibilities

  • Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
  • Ensure compliance with FDA Quality System Regulations, EU MDR, and in-house Standards.
  • Participate on cross-functional teams to develop product risk management files.
  • Partner with Software Engineering to assess risk and develop software design plans.
  • Assist in creating verification and validation plans, protocols, and reports.

Requirements

  • B.E or B.Tech degree in a relevant field.
  • Minimum 5-8 years of quality engineering experience or equivalent.
  • Familiarity with statistical software tools (Minitab, Stat Graphics).
  • Knowledge of ISO 9001, ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR, and product-specific industry standards.

Benefits

  • A competitive salary of $120,000 - $180,000 per year, based on experience.
  • The opportunity to work with a global leader in medical technology.
  • A dynamic and collaborative work environment.
  • Ongoing training and development opportunities.

About Medtronic

Medtronic is a leading global healthcare technology company that provides innovative medical technologies and solutions to help alleviate pain, restore health, and extend life.



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