Principal Software Quality Engineer

Mg Staffing Group

1d • Onsite

About The Position

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

• 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
• 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
• 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 Haves

• Additional investigation and root cause analysis expertise

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level