Senior Quality Assurance Engineer
3 weeks ago
Job Summary:
Katalyst Healthcares and Life Sciences is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our medical devices.
Key Responsibilities:
- Evaluate requirements for quality and completeness to ensure they meet user needs
- Develop test methods to evaluate X-ray image quality and consistency
- Reduce test burden through automation of existing and new testing
- Test advanced image reconstruction and processing algorithms
- Design custom test phantoms and fixtures with internal and external teams
- Ensure compliance with standards and regulations, including ISO and FDA QSR
- Participate in product development phases, including requirements, design, usability, risk assessment, and defects
- Provide technical leadership and mentoring to test engineers
- Identify and catalog software defects in assigned functional areas
- Assist in triage, investigation, and resolution of software defects related to X-ray image quality
- Plan and execute test process improvements to enhance Test Engineering team performance
- Generate test plans and protocols based on product requirements and project needs
- Document and report test results
- Effectively communicate and present findings, problems, and solutions within the team
- Maintain excellent working relationships with team members and stakeholders
- Perform duties in compliance with the Quality System and environmental, health, and safety regulations
Requirements:
- Solid understanding of federal and international medical device regulations, such as FDA QSR, ISO 14971, 62304, and 13485, and EU MDR
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