
Software Validation Engineer
Lead validation activities in the implementation of Manufacturing Execution Systems (MES). Work closely with business management and validation departments to strategically define validation approaches and solutions. Develop the Validation deliverables including Quality Assurance Plans, Validation and Testing Plans, Design Documents, Test Protocols and Summary Responsible for writing Standard Operating Procedures to support Medical Device industry regulations and requirements including FDA 21 Code of federal regulations part 11. Participate in Release Testing and Post Test Reviews as scheduled. Ensure the proper execution of software test plans and test approaches. Analyze requirements during the requirements analysis phase of projects. Keep track of the new changes to requirements. Co-ordinate and conduct informal and formal testing of MES solutions. Arrange the Hardware and software requirement for the Test Setup. Track and report testing activities, defects discovered and their status, etc. for each release.
3+ years’ experience with Software Quality Assurance, testing methodologies, and application software development processes.
MES Camstar validation
Must have strong Manufacturing and SCM domain knowledge.
Solid knowledge of SDLC processes both: Waterfall and Agile.
C#
Time Management Skills
21 CFR Regulation
Black box and grey box testing techniques
Java Enterprise systems
Verbal communication
Driven and self-motivated
written communication
Detail Oriented and Organized
Multi-tasker
According to JobzMall, the average salary range for a Software Validation Engineer in 7475 Lusk Blvd, San Diego, CA 92121, USA is $74,000 to $103,000 per year. The salary range is based on factors such as experience, qualifications, employer, and location.
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We believe in advancing the global adoption of less invasive surgery to help patients around the globe suffering from back pain. Through the integration of industry-leading procedures and enabling technologies, we advance the standard of care to help hundreds of thousands of patients each year. Our commitment is to deliver the safest, most efficient technology in the OR to help improve clinical and economic outcomes.

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