Software Quality Engineer II

• Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
  
• Conduct evaluations of software systems activities including requirements, design, development, documentation, integration, testing, verification, and validation.
  
• Define appropriate measures to ensure product quality.
  
• Develop overall operating criteria to ensure implementation of the software quality program in compliance with project, process, and contract requirements.
  
• Ensure project and process control documentation meet requirements, objectives, and/or contracts.
  
• Review software systems design, change specifications, and plans against contractual and/or process requirements.
  
• Assess specifications, materials, tools, techniques, and methodologies for compliance.
  
• Provide or direct verification and validation of software system requirements, traceability, and testability.
  
• Perform other duties as assigned.
  

Requirements

• Minimum 3 years of field experience in Quality, Engineering, or Programming in the regulated industry.
  
• Experience with risk management documentation (pFMEAs).
  
• Basic knowledge in PLC, general programming, and source code review.
  
• Ability to support CAPA investigations and provide technical writing.
  
• Knowledge of designing and reviewing validation strategies (requirements flow down from design to manufacturing).
  
• Ability to perform and/or review process/equipment validation documentation: URS, FAT, IQ, OQ, PQ, TMV (not laboratory).
  
• Familiarity with Medical Device Regulations and GAMP guidelines.
  

• Investigation and root cause analysis skills.
  

• Technical writing knowledge.
  

• Strong organization and communication skills.
  

• Process validation and computer software validation knowledge.
  

• Ability to use statistical techniques to analyze data.
  

• Experience in medical device manufacturing.
  

• Interpersonal skills to investigate and collaborate in atypical event investigations.
  

• pFMEA development and review.
  

• Automated source code management.
  

• Computer software programming.
  

• Embedded software programming.
  

• Development of control plans and PFMEA.
  

• Additional experience with investigation and root cause analysis.
  

1. Automation, controls, and programming hands-on experience.
   

2. CAPA, investigations, root cause analysis, and technical writing.
   

3. Computer software validations and GAMP knowledge (hands-on).