Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are looking for a Senior Software Quality Engineer who will
- Be involved in managing the implementation and maintenance of systems and tools that support Tempus Quality Management System (QMS), software development life cycle (SDLC) and design controls activities
- Perform and support computer system validation (CSV) activities; testing and evaluation of software tools and computer systems against user requirements
- Support medical device software design controls activities
in accordance with FDA Quality System Regulation (QSR), ISO 13485, Computer System Validation (CSV) and other applicable regulatory requirements, as well as best practices in the software industry. This position will report to the Senior Manager, Software Quality.
- Implementation and maintenance of QMS software and SDLC tools:
- Manages and supports the implementation and maintenance of computer systems and software tools (such as eTQ and JAMA) that are used for the purposes of supporting the QMS, SDLC and design controls activities.
- Evaluates user needs, and suggests solutions and system configurations that support organizational compliance and quality processes.
- Defines and manages user needs and supports the execution of implementation.
- Serves as a liaison between third-party system/tool vendors during/after system implementation, and during the process of troubleshooting/resolving user experience issues.
- Facilitates system training, UAT testing activities, and scoping development of proposed system enhancements.
- Provide quality support to comply with the Computer Systems Validation (CSV) processes:
- Performs and supports the validation of regulated software applications by ensuring CSV activities, testing and evaluation of software tools and computer systems against design specifications and user requirements, are compliant to 21 CFR Part 11 and organization's CSV process.
- Works autonomously with related SMEs for this purpose.
- Supports software engineering teams as quality representative for the development, testing and implementation of computer systems and software tools.
- Collaborates with the software development team to build compliance capabilities and requirements in order to assure the quality of the deliverables and ensures business and regulatory needs are being met.
- Drives and defends validation compliance to internal/external auditors, regulatory authorities and other certified bodies.
- Ensures continuous improvement and implements inputs related to the validation strategy for systems and software tools changes.
- Ensures quality risk management principles and practices by driving teams towards risk-based approach to CSV.
- Ensures good documentation practices and assists with required documentation for compliance purposes.
- Write SOPs and various CSV deliverables, as needed.
- Provide training to project teams related to Tempus CSV standards and processes.
- Support medical device software design controls activities as assigned:
- Support writing, review and approval of DHF (Design History File) deliverables
- Support FMEA and risk management activities as per ISO 14971
- BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
- 5+ years in a quality role in the medical device/IVD (or FDA regulated) industry.
- Experience and working knowledge of applicable regulations and standards: FDA QSR, ISO 13485, IEC 62304, ISO 14971, CSV, 21 CFR Part 11.
- Experience with SDLC tools: JAMA JIRA, Atlassian, eTQ.
- Demonstrated ability to operate and innovate in teams with a fast‐paced environment, balancing business, compliance, and strategic needs.
- Experience with Agile/Scrum/iterative software development methodology.
- Excellent organizational, interpersonal, verbal and written communication skills.
- Ability to deliver quality outputs under minimal supervision.
- Flexibility to adapt to changing assignments and ability to effectively prioritize efforts.
- The role must maintain compliance expertise and be effective at applying requirements into the computer systems environment that supports business goals and maintaining a compliant state.