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About the Job
The QA Software Quality Specialist is responsible for safeguarding the software development lifecycle of a suite of software applications. The incumbent will assist the software development teams with formulating well-articulated documents that satisfy regulatory requirements, so that those external to the development process without a software background will understand at a high level. As a member of Quality Assurance, the Software Quality Specialist is key in the performance of QA activities for software applications in the medical devices, and also acts as a bridge to the technology organizations charged with developing and deploying the applications. The Software Quality Specialist will regularly interact with technology software developments teams, product managers, laboratory equipment managers, QA colleagues, and occasional interaction with external auditors - such as regulatory agencies and Pharma partners.
• Review and critique software design-related documentation.
• Advise SW development teams on SW architecture issues that facilitate regulatory compliance.
• Advise on and review Computer Systems Validation activities.
• Participate in the creation and updating of processes and work instructions.
• Provide guidance on SW development lifecycle process and regulatory requirements.
• Make decisions based on the applicable processes and standard.
• Perform internal audits of SW projects and external audits of suppliers.
• Maintain availability to work outside regularly scheduled shift.
• Travel domestically up to 10% of the time.
• Other duties as assigned.
• Bachelor’s Degree in software engineering, computer science, or scientific/engineering discipline
• 3+ years of prior experience with quality systems and/or SW quality for medical device or healthcare software development
• 2+ years of prior experience with Agile SW development practices
• Proficiency with relevant medical SW regulations: 21CFR Part 11/annex 11, Part 820, Part 812, part 814; IEC 62304, ISO 14971, ISO 13485
• Demonstrated and significant contributions to an FDA software submission
• Solid understanding of SDLC, familiarity with Software Requirements Documents, Software Detailed Design Documents, Software trace matrix documents, software Architectural design documents, and risk assessment documentation as either an author of these documents or as someone who has reviewed them regularly
• Demonstrated understanding of software coding constructs and systems such as Confluence, JIRA and various script languages such as Python
• Direct experience working with regulatory, QA and software development teams
• Experience with Computer Systems Validation methods and standards
• Knowledge on SW version control and version management
• Ability to work in an environment that can change quickly and may be loosely structured at times
• Comfortable providing compliance guidance to software development teams
• Excellent organization and attention to detail
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI’s values: Patients, Collaboration, Innovation, and Passion
Internal applicants, please use your FMI email address.
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