Sr. Quality Engineer

Tempus AI•Chicago, IL

11d

About The Position

Tempus is seeking a Senior Software Quality Engineer to support systems and tools used in its Quality Management System (QMS), software development life cycle (SDLC), and medical device software design controls. The role manages implementation and maintenance of quality and SDLC software, evaluates user needs and system configurations, coordinates with third-party vendors, and supports training, user acceptance testing, and proposed enhancements. The position performs and supports computer system validation (CSV) for regulated software applications, ensuring testing and evaluation against design specifications and user requirements comply with 21 CFR Part 11 and Tempus CSV processes. Working with subject matter experts and software engineering teams, the role helps build compliance capabilities, applies risk-based CSV practices, maintains documentation, prepares SOPs and CSV deliverables, and supports audits and regulatory interactions. It also supports medical device software design controls, including Design History File deliverables and risk management activities.

Requirements

Five or more years in a quality role in the medical device/IVD or FDA-regulated industry.
Experience and working knowledge of FDA QSR, ISO 13485, IEC 62304, ISO 14971, computer system validation, and 21 CFR Part 11.
Experience with SDLC tools, including JAMA, JIRA, Atlassian, and eTQ.
Experience with Agile, Scrum, or iterative software development methodologies.
Demonstrated ability to work and innovate in a fast-paced team environment while balancing business, compliance, and strategic needs.
Excellent organizational, interpersonal, verbal, and written communication skills.
Ability to deliver quality outputs under minimal supervision.
Flexibility to adapt to changing assignments and effectively prioritize efforts.
Ability to maintain compliance expertise and apply requirements in computer systems environments to support business goals and maintain a compliant state.

Nice To Haves

BA/B.S. or higher in Computer Science, Software Engineering, Informatics, Biomedical Engineering, or a relevant engineering discipline.

Responsibilities

Manage and support implementation and maintenance of computer systems and software tools used for QMS, SDLC, and design controls activities, including eTQ and JAMA.
Evaluate user needs and recommend solutions and system configurations that support compliance and quality processes.
Define and manage user needs and support system implementation.
Liaise with third-party system and tool vendors during and after implementation and when troubleshooting user experience issues.
Facilitate system training and user acceptance testing, and scope proposed system enhancements.
Perform and support validation of regulated software applications, including testing and evaluation against design specifications and user requirements.
Ensure CSV activities comply with 21 CFR Part 11 and organizational CSV processes.
Support software engineering teams as the quality representative during development, testing, and implementation of computer systems and software tools.
Collaborate with software development teams to build compliance capabilities and requirements and ensure business and regulatory needs are met.
Drive and defend validation compliance with internal and external auditors, regulatory authorities, and other certified bodies.
Support continuous improvement and provide input to validation strategies for system and software tool changes.
Promote quality risk management principles and risk-based approaches to CSV.
Ensure good documentation practices and prepare required compliance documentation, SOPs, and CSV deliverables.
Train project teams on Tempus CSV standards and processes.
Support medical device software design controls, including writing, reviewing, and approving Design History File deliverables.
Support FMEA and risk management activities in accordance with ISO 14971.