Medical Device Quality Assurance Specialist

3 weeks ago


Delray Beach, Florida, United States TRAC Recruiting Full time
Job Title: Medical Device Quality Engineer

We are seeking a highly skilled Medical Device Quality Engineer to join our team in Boca Raton, FL. As a Medical Device Quality Engineer, you will play a critical role in ensuring the quality and safety of our medical devices.

Key Responsibilities:
  • Develop and implement quality assurance processes to ensure compliance with regulatory requirements, such as ISO 13485:2016, FDA's regulations (e.g., 21 CFR Part 820), EU MDR, and MDSAP regulations.
  • Design and implement software validation and verification processes to ensure that software meets required quality standards.
  • Collaborate with software developers to ensure that software development processes meet regulatory requirements and quality standards.
  • Identify and mitigate risks associated with software used in medical devices to ensure patient safety.
  • Develop and maintain documentation related to software development processes, testing procedures, and quality assurance activities.
Requirements:
  • Minimum of Associate or BS degree in Computer Science, Software, Electronics, or Electrical Engineering or Equivalent.
  • Experience following code execution paths.
  • Experience with OOP architecture.
  • Strong knowledge of the software development life cycle.
  • Experience with code repositories (Git preferred).
  • Knowledge of ISO 13485:2016, FDA's regulations (e.g., 21 CFR Part 820), EU MDR, and MDSAP regulations a plus.
  • Experience in Software Verification and Validation, Software QA Testing.
Benefits:
  • Paid Time Off.
  • Medical/Dental Insurance.
  • 401(k).


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