Software Quality Engineer

Location:
Ft. Lauderdale, FL

Job Description:

• The Software Quality Engineer will provide support during the software development process to ensure compliance with the company’s quality system and other relevant standards
• Provide hands-on testing of System software
• Review and maintenance and development of automated testing scripts
• Maintenance and update of software quality documentation, testing checklist
• Administration of bug / feature request tracking system
• Ensure compliance with company Quality System, FDA QSR, and ISO quality system standard
• Support Quality System reporting to management

• Integral member of the software development team during the design of new software products and software changes or enhancements
• Develop Quality Plans for the software development team
• Partner with software engineering to create, conduct, and perform design verification and validation testing relating to software
• Generate effective software testing reports
• Support supplier assessments related to software when necessary
• Support quality system maintenance as it relates to software
• Review quality metrics (e.g. NPR’s, complaints, service calls, etc.) for opportunities to correct and prevent software related issues
• Lead or contribute as a member of CAPA teams to analyze and correct software quality issues
• Develop software quality assurance documentation to support regulatory submissions and assure completeness of the Design History File
• Evaluate software changes for impact to verification and validation requirements and assist in change implementations
• Other functions include to develop new software quality initiatives, participate in quality system development, procedure writing and review, and to improve quality and reliability of software
• RParticipate in internal audits for compliance to company procedures relating to software development
• Develop and deploy training to employees on company Quality System requirements as it relates to software

• BS in MIS, Computer Science or Engineering is required; min 4 years experience in software testing and QA
• Strong technical writing skills
• Familiarity with Linux/Unix, scripting languages (e.g. TCL)
• Demonstrated experience using Windows, Microsoft Office, and Outlook
• Knowledge of FDA QSRs and ISO 9000 quality system standards is desirable
• Experience in a regulated software development environment desirable
• American Society for Quality Certification: Certified Software Quality Engineer (CSQE) desirable
• Familiarity with 21 CFR Part 11 Electronic Records; Electronic Signatures is a plus