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Medical Device Quality Assurance Specialist
1 month ago
We are seeking a Medical Device Quality Engineer to join our team at TRAC Recruiting, Inc. in Delray Beach, FL. This is a full-time role with a fast-growing biomedical company in the oncology and biomedical IT field.
Responsibilities:- Develop and maintain medical devices in a dynamic and fast-paced environment.
- Design and implement quality assurance processes, including creating test plans, conducting testing, and ensuring software defects are identified and addressed.
- Ensure software development processes and products comply with regulations, including ISO 13485:2016, FDA's regulations (e.g., 21 CFR Part 820), EU MDR, and MDSAP regulations.
- Work closely with software developers and lead software verification and validation efforts.
- Engage with quality assurance and operations teams, regulatory affairs professionals, and other stakeholders to ensure software development processes meet regulatory requirements and quality standards.
- Identify and mitigate risks associated with software used in medical devices to ensure patient safety.
- Create and maintain documentation related to software development processes, testing procedures, and quality assurance activities.
- Continuously improve and enhance product quality to comply with evolving regulations by identifying opportunities for process improvement and implementing best practices to enhance software quality.
- 2+ years of experience with active medical devices like Electromechanical and Xray.
- Knowledge of ISO 13485:2016 is required.
- FDA's regulations like 21 CFR Part 820, EU MDR, and MDSAP regulations are a plus.
- Experience with software verification and validation for software QA testing.
- Strong knowledge of the software development life cycle (SDLC).
- Experience with code repositories like Git.
- Experience following code execution paths.
- Experience with OOP architecture.
- Understanding and the ability to follow the code with Java, C++, NodeJs, and JavaScript is a plus.
- Experience with MySQL databases, UML diagrams, and Jira is a plus.
- Minimum of Associate or BS degree in Computer Science, Software, Electronics, Electrical Engineering, or Equivalent.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. You must be legally authorized to work in the United States without current or future sponsorship.
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