Engineer, Software Quality - Senior or Lead

himanshi.pandit@generistek.com

• Develops validation plan based on the software requirements.
• Designs test cases and create procedures for conducting tests.
• Implements test procedures, collects and analyzes test results.
• Conducts analyses of problems related to documentation and/or testing and initiate corrective actions.
• Develops validation report based on the test results.
• Provides technical guidance and support to other engineers and /or technicians.
• Provides technical and analytical support to production to define and resolve problems.

• Bachelor’s Degree in a relevant engineering discipline (e.g. Computer Science, Electrical/Electronic Engineering, Mechanical Engineering, Computer Engineering), a physical science, a related field (i.e. Quality, Reliability, Microelectronics), or equivalent. 

• Quality Engineer Certification (CQE) certification and/or experience in a regulated medical industry are desired.

• Medical device software validation experience – Proven background testing and validating software in a regulated environment (FDA/ISO), including preparing validation documents and supporting audits.
• Experience with data systems and testing – Ability to test complex systems that manage and move data, ensuring accuracy, integrity, and reliable system integrations.
• Strong documentation and risk-based thinking – Skilled at writing clear validation documents and focusing testing on the highest-risk areas to ensure compliance and quality, with strong judgment, ownership, and efficiency efficiently leveraging tools and resources to get high-quality work done.

himanshi.pandit@generistek.com