Engineer, Software Quality Senior or Lead

Duties & Responsibilities

• Develops validation plan based on the software requirements;
• Designs test cases and creates 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

Minimum Education Requirements

• Bachelors 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.

Required Certifications (if applicable)

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

Top Three Must Have Skills or Experience you are looking for in a successful candidate-

• 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.