Software Quality Engineer II
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, testing, verification, and validation. Define measures to ensure product quality and establish operating criteria for compliance with project, process, and contract requirements. Review design specifications and plans against contractual and process standards, assessing tools and methodologies for compliance. Provide verification and validation of requirements, traceability, and testability. Support CAPA investigations and perform root cause analysis using statistical techniques. Work 100% on-site in Juncos during 1st and 2nd shifts. Requires minimum 3 years of field experience in Quality, Engineering, or Programming within the regulated industry.
Required Qualifications
- 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
- Willing to work 100% On-site in Juncos, 1st and 2nd shift
Desired Qualifications
- Additional experience with investigation and root cause analysis
- Automation, controls, and programming hands-on experience
- CAPA, investigations, root cause analysis, and technical writing
- Computer software validations and GAMP knowledge (hands-on)
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