Principal Software Quality Engineer

Responsibilities may include the following and other duties may be assigned:

• Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
  
• Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
  
• Define and implement appropriate measures to ensure product quality.
  
• Review software systems design, change specifications, and project plans against contractual and regulatory requirements.
  
• Ensure compliance with applicable specifications, tools, techniques, and methodologies.
  
• Provide or direct verification and validation of software system requirements, traceability, and testability.
  
• Lead and oversee projects from design to implementation, ensuring compliance with policies and industry regulations.
  
• Represent the organization as primary contact for projects/initiatives, communicating with internal and external stakeholders.
  
• Provide mentorship, coaching, and training to other professionals within the team.
  

Requirements

Experience

• Minimum 7 years of relevant experience in quality, engineering, or programming (excluding laboratory micro/chemistry experience).
  

• Advanced degree accepted with minimum 5 years of relevant experience.
  

• Automation / Controls / Programming hands-on experience
  
• CAPA, investigations, root cause analysis, and technical writing
  
• Computer software validations and GAMP knowledge – hands-on experience
  
• (Additional) Strong knowledge in medical devices regulations
  
• Experience with risk management documentation (PFMEAs)
  

• Experience designing validation strategies (e.g., requirements flow down from design to manufacturing)
  

• Perform and/or review process validation and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not cleaning or laboratory processes)
  

• Knowledge of medical device regulations and GAMP standards
  

Education

• Bachelor’s degree in Engineering (Mechanical, Electrical, or Computer/Software preferred).
  

Technical Skills

Must Have

• Investigation and root cause analysis skills
  
• Technical writing knowledge
  
• Strong organizational and communication skills
  
• Process validation and computer software validation knowledge
  
• Ability to apply statistical techniques to analyze data and develop/review/approve test plans and reports
  
• Experience in medical devices manufacturing
  
• Interpersonal skills to support product disposition investigations (PFMEA, atypical events)
  
• Automated source code management
  
• Computer software programming (including embedded software programming)
  
• Development of control plans and PFMEA
  

Additional Technical Areas (Hands-On/Knowledge Required)

• Programmable Logic Controllers (PLC): Rx Logix configuration & troubleshooting
  
• Vision Systems
  
• Instrumentation: overview and application
  
• Control Systems
  
• Data Structure & Sources
  
• Data Analysis Tools: SQL, Python, R
  
• Data Management
  
• Databases: data extraction, transformation, loading, database creation/maintenance, query overview (SQL/Non-SQL)
  
• Programming: Assembly (C), Object-Oriented Programming (Python, Java), error handling, abstract data types
  
• GUI/HMI Design: FactoryTalk, RSView
  
• Communication Networks
  
• Operating Systems
  
• FDA CSA Guidance: knowledge of Computer Software Assurance (CSA) for production and quality system software (FDA Draft Guidance, 2022)
  

Nice to Have

• Additional investigation and root cause analysis expertise