ThunderSoft Hiring! Full Time Staff V-V Software System Engineer in Pulau Pinang - Ricebowl

Essential Duties and Responsibilities:

• Assist with development of test plans, test cases, and test scripts on multiple projects simultaneously.
• Experience with medical or similar regulated manufacturing systems and processes.
• Experience with positive and negative outcomes in the manufacturing process with a focus on failure and reject modes.
• Independently define and enforce the strategies for integration, system, and regression testing and test environment during V&V.
• Create, track, and complete regulated documentation for SW V&V process such as change orders, test plans, reports, and relevant attachments.
• Review and update documentation in response to feedback from stakeholders.
• Participate in design review and change control meetings.
• Work with developers or vendors to perform root-cause analysis and preliminary problem diagnosis.
• Identify defects and track them from discovery to resolution.
• Conduct manual and automated testing of software.
• Quickly learn all essential aspects of fast paced manufacturing testing system.
• Basic SQL Knowledge for (SELECTS, JOINS, and execution)
• Other duties as assigned

Required Qualifications:

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5 years related experience or Master’s degree and 3 years equivalent industry experience.

Preferred Qualifications:

• Experience with data processing and reporting systems.
• Proficient in all software testing phases.
• Understand medical device software development process and participate in efforts to improve SDLC processes.
• Extensive experience working as a quality engineer for product manufacturing software or developing or validating software for product manufacturing equipment.
• Quick learner and adjust easily to a dynamic, fast paced environment
• SQL query modification and execution.
• User Interface testing experience.
• Familiar with JIRA, Valgenesis, and/or Smartsheet.
• Experience in software for operating manufacturing or testing equipment.
• Experience in FDA regulated software development.
• Python programming a plus.
• Experience in using documentation, task, defect, requirement, and test case management systems such as Oracle Agile PLM, Jira, ValGenesis, or similar.
• Experience with 21 CFR Part 11 compliant systems.
• Familiarity with 21 CFR 820 a plus.
• Experience with ISA 95 model a strong plus.