Position Overview: We are seeking a talented and detail-oriented Software Tool Validation Specialist to join our QualiTest team. The ideal candidate will be responsible for ensuring the compliance and effectiveness of software tools used in medical applications through rigorous validation processes.
Responsibilities:
· Develop and execute validation protocols, including test plans, test cases, and test scripts, for software tools used in medical devices or healthcare systems.
· Collaborate with cross-functional teams, including software engineers, quality assurance, regulatory affairs, and product management, to define validation requirements and ensure alignment with regulatory standards (e.g., FDA, ISO).
· Conduct risk assessments to identify potential hazards and mitigate risks associated with software tool functionality and performance.
· Perform verification and validation testing activities, including functional testing, integration testing, regression testing, and performance testing, to verify software tool requirements and specifications.
· Document validation activities, findings, and test results in compliance with regulatory requirements and internal quality management systems.
· Participate in design reviews, software development life cycle (SDLC) meetings, and change control processes to ensure validation considerations are addressed throughout the software development process.
· Stay abreast of industry trends, regulatory changes, and best practices related to software validation in the medical domain.
Qualifications:
· Bachelor's degree in Computer Science, Engineering, Biomedical Engineering, or a related field; Master's degree preferred.
· Minimum of 5 years of experience in software validation, preferably in the medical device or healthcare industry.
· Strong understanding of software development life cycle (SDLC) processes, software validation methodologies, and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
· Experience developing and executing validation protocols, test plans, and test cases for software applications.
· Familiarity with Off the shelf (OTS) software tools validation is a plus.
· Familiarity to Qt, Linux, Ubuntu flavors, CPP/VTK is a plus. Exposure DICOM, HLS/RIS standards is plus.
· Proficiency in using validation tools and techniques, such as automated testing tools, risk analysis methods (e.g., FMEA), and statistical analysis.
· Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and communicate technical concepts to non-technical stakeholders.
· Certifications such as Certified Software Quality E
3 must haves
Validation Testing experience 4/5
Knowledge of validation methodologies such as FDR, CFR 4/5
Communication excellent 3/5
Why QualiTest?
Have continuous access to and work with Senior Testing Specialists and Practice Experts
Be a part of a leading testing company, globally recognized as a Visionary by Gartner Magic Quadrant
Work with cutting edge technology in a company built by testers for testers, this is what we do!
As a global company, we offer unique placement opportunities around the world
Our QualiTesters are the reason for our success, we constantly encourage career development and promote from within
Intrigued to find more about us?
Visit our website at www.qualitestgroup.com
Check out our Career page: http://qa-jobs.qualitestgroup.com/
