Essential Duties and Responsibilities:
- Assist with development of test plans, test cases, and test scripts on multiple projects simultaneously.
- 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 7 years related experience or Master's degree and equivalent industry experience.
Preferred Qualifications:
- Experience with data processing and reporting systems.
- Experience with medical manufacturing systems and processes.
- 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
- Intermediate Python programming.
- 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.
- Experience in using documentation, task, defect, requirement, and test case management systems such as Oracle Agile PLM, Jira, ValGenesis, or similar.
- Expertise in 21 CFR Part 11 compliant systems.
- Familiarity with 21 CFR 820 a plus.
- Experience with ISA 95 model a strong plus.
