Medical Device Quality Assurance Specialist
3 weeks ago
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.
- 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.
- Paid Time Off.
- Medical/Dental Insurance.
- 401(k).
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Medical Device Quality Assurance Specialist
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Delray Beach, Florida, United States TRAC Recruiting Full timeJob Title: Medical Device Quality EngineerWe 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.Job Summary:The Medical Device Quality Engineer will be responsible for designing and...
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Medical Device Quality Assurance Specialist
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Delray Beach, Florida, United States TRAC Recruiting Full timeJob Title: Medical Device Quality EngineerWe 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.Job Summary:The Medical Device Quality Engineer will be responsible for designing and...
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Medical Device Quality Assurance Specialist
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