Principal Software Quality Engineer

Juncos, Puerto Rico

Responsibilities may include the following and other dutiesmay be assigned:

• Develop,modify, apply, and maintain standards for software systems qualityoperating methods, processes, and procedures.
  
• Conductevaluation of software systems activities including requirements, design,development, documentation, integration, test, verification, andvalidation.
  
• Defineand implement appropriate measures to ensure product quality.
  
• Reviewsoftware systems design, change specifications, and project plans againstcontractual and regulatory requirements.
  
• Ensurecompliance with applicable specifications, tools, techniques, andmethodologies.
  
• Provideor direct verification and validation of software system requirements,traceability, and testability.
  
• Leadand oversee projects from design to implementation, ensuring compliancewith policies and industry regulations.
  
• Representthe organization as primary contact for projects/initiatives,communicating with internal and external stakeholders.
  
• Providementorship, 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.

• 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

• Investigationand root cause analysis skills
  
• Technicalwriting knowledge
  
• Strongorganizational and communication skills
  
• Processvalidation and computer software validation knowledge
  
• Abilityto apply statistical techniques to analyze data and develop/review/approvetest plans and reports
  
• Interpersonalskills to support product disposition investigations (PFMEA, atypicalevents)
  
• Automatedsource code management
  
• Computersoftware programming (including embedded software programming)
  
• Developmentof control plans and PFMEA
  

Additional Technical Areas (Hands-On/Knowledge Required)

• ProgrammableLogic Controllers (PLC): Rx Logix configuration & troubleshooting
  
• VisionSystems
  
• Instrumentation: overview and application
  
• ControlSystems
  
• DataStructure & Sources
  
• DataAnalysis Tools: SQL, Python, R
  
• DataManagement
  
• Databases: data extraction, transformation, loading, database creation/maintenance,query overview (SQL/Non-SQL)
  
• GUI/HMIDesign: FactoryTalk, RSView
  
• CommunicationNetworks
  
• OperatingSystems
  
• FDACSA Guidance: knowledge of Computer Software Assurance (CSA) forproduction and quality system software (FDA Draft Guidance, 2022)
  

Nice to Have

• Additionalinvestigation and root cause analysis expertise
  

*Willing to work 1st or 2nd shift and 100% on-Site in Juncos.*