What are the responsibilities and job description for the Regulatory Compliance Tester position at Katalyst HealthCares and Life Sciences?
Overview
At Katalyst HealthCares and Life Sciences, we are committed to developing innovative medical diagnostic devices that meet the highest quality and safety standards. We are seeking an experienced QA Tester to join our team and contribute to this mission.
Job Summary
The QA Tester will be responsible for ensuring that software for our medical diagnostic devices is rigorously tested, compliant with regulatory standards, and meets high quality and safety standards. This role requires strong analytical and problem-solving skills, as well as the ability to work independently and collaboratively as part of a team.
Key Responsibilities
* Develop and execute test plans and test cases to validate software functionality and performance
* Collaborate with cross-functional teams to identify and address defects
* Ensure compliance with regulatory requirements and organizational QMS standards
* Document and track software defects and issues
* Participate in training and development activities to stay up-to-date with industry developments and best practices
What We're Looking For
* Bachelor's degree in Computer Science, Engineering, or related field
* 8-10 years' experience in software testing for medical devices
* In-depth knowledge of regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304)
* Strong understanding of agile development methodologies
* Excellent communication and collaboration skills
Why Join Us?
We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. If you are passionate about delivering high-quality products and improving patient outcomes, we encourage you to apply for this exciting opportunity.
At Katalyst HealthCares and Life Sciences, we are committed to developing innovative medical diagnostic devices that meet the highest quality and safety standards. We are seeking an experienced QA Tester to join our team and contribute to this mission.
Job Summary
The QA Tester will be responsible for ensuring that software for our medical diagnostic devices is rigorously tested, compliant with regulatory standards, and meets high quality and safety standards. This role requires strong analytical and problem-solving skills, as well as the ability to work independently and collaboratively as part of a team.
Key Responsibilities
* Develop and execute test plans and test cases to validate software functionality and performance
* Collaborate with cross-functional teams to identify and address defects
* Ensure compliance with regulatory requirements and organizational QMS standards
* Document and track software defects and issues
* Participate in training and development activities to stay up-to-date with industry developments and best practices
What We're Looking For
* Bachelor's degree in Computer Science, Engineering, or related field
* 8-10 years' experience in software testing for medical devices
* In-depth knowledge of regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304)
* Strong understanding of agile development methodologies
* Excellent communication and collaboration skills
Why Join Us?
We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. If you are passionate about delivering high-quality products and improving patient outcomes, we encourage you to apply for this exciting opportunity.
