Principal Software Quality Engineer
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Develop and maintain standards for software systems quality operating methods, processes, and procedures. Conduct evaluations of software activities including requirements, design, development, documentation, integration, test, verification, and validation. Define measures to ensure product quality and review designs against contractual and regulatory requirements. Lead projects from design to implementation while representing the organization as the primary contact for internal and external stakeholders. Provide mentorship, coaching, and training to team professionals. This role requires a minimum of 7 years of relevant experience in quality, engineering, or programming, with hands-on expertise in automation, controls, and programming. Candidates must demonstrate knowledge of medical device regulations, GAMP standards, and process validation strategies, including URS, FAT, IQ, OQ, and PQ. Proficiency in risk management documentation, root cause analysis, and statistical techniques for test plan development is essential. Willingness to work 1st or 2nd shift and 100% on-site in Juncos is required.
Required Qualifications
- 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
- 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
- Bachelor's degree in Engineering (Mechanical, Electrical, or Computer/Software preferred)
- 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)
- Willing to work 1st or 2nd shift and 100% on-Site in Juncos
Desired Qualifications
- Computer/Software preferred
- Additional investigation and root cause analysis expertise
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