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Job Description |
Duties: Responsibilities:
•Establish the initial software testing environment, including processes and tools to support the processes in a most efficient manner.
Work with cross-functional stakeholders to get the infrastructure 21 CFR Part 11
compliant•Establish software test, verification, and validation guidelines and ensure their implementation through conducting design reviews for source code coming from internal and external sources•
Work closely with the software development team to ensure proper testing, verification and validation coverage
•Work with internal and external software developers and testers to ensure software testing, verification, and validation deliverables are meeting expectations with respect to quality
•Lead the software testing, verification, and validation aspects of ongoing projects and drive the overall strategy to accomplish satisfactory test coverage
•Support continuous improvement through software test, verification, and validation metrics and ensure consistent visibility into those for every project executed
•Establish an Agile culture of testing, testing often and early by working in a closely integrated fashion with software developers as well as incrementally building up the verification test protocols that get informally executed along the progression of the project but formally documented at the end.
Operational:
•Complying with policies and processes and ensure they are communicated, understood, implemented, and maintained at all levels of the organization
•Demonstrating excellent partnership and collaboration with other functions within the company to support common initiatives on medical devices
•Demonstrating knowledge, skill and ability to model the Sanofi values and positively communicates the company visions, values, priorities and target
Skills: Desired skills
:•MS in Computer Science or equivalent
•Experience in cloud based deployments of medical software devices
•Experience in privacy, security, HIPPA, databases, SQL, Obective-C, and mobile apps
Keywords:
Education: Requirements:
BS in computer science or equivalent
5-10 years of experience in software testing, verification, and validation
5+ years of experience in leading complex software testing projects and other testers
5+ years of experience in test case management/execution and test automation
5+ years of experience in white-box and black-box testing
5+ years of hands-on experience in test automation and respective tools
5+ years of hands-on experience in server / cloud based service and DB testing
3+ years of hands-on experience in UI testing, including mobile and web based platforms
2+ years of experience in Agile software development and testing
2+ years of experience in design controls and FDA / ISO 13485 / IEC 62304 compliant software development
Excellent verbal and written communication skills.
Demonstrated initiative and analytical thinking style, able to comprehend complex problems and good problem solving skills
Proven track record of being a strong team player
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