Sr. Quality Engineer

Tempus AI•Redwood City, CA

2d•$110,000 - $165,000

About The Position

Tempus is seeking a Senior Software Quality Engineer to manage and support systems and tools used for its Quality Management System (QMS), software development life cycle (SDLC), and design controls. The role performs and supports computer system validation (CSV), including testing and evaluating software tools and computer systems against user requirements. It also supports medical device software design controls in accordance with FDA Quality System Regulation (QSR), ISO 13485, CSV requirements, and other applicable regulations and software-industry best practices. The position reports to the Senior Manager, Software Quality. The engineer manages implementation and maintenance of QMS and SDLC software tools, evaluates user needs and system configurations, coordinates with third-party vendors, and facilitates training, user acceptance testing, and proposed enhancements. The role partners with software engineering and subject-matter experts on compliant system development and validation, supports risk-based CSV and audit readiness, maintains documentation, writes SOPs and CSV deliverables, and supports design history file and risk-management activities. The listed salary ranges are $110,000–$155,000 for Chicago/National and $120,000–$165,000 for NY/SF. The posting notes that actual salary may vary by location, qualifications, and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

Requirements

Bachelor of Arts, Bachelor of Science, or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or a relevant engineering discipline.
At least 5 years in a quality role in the medical device, IVD, or FDA-regulated industry.
Working knowledge of applicable regulations and standards, including FDA QSR, ISO 13485, IEC 62304, ISO 14971, CSV, and 21 CFR Part 11.
Experience with SDLC tools, including JAMA, JIRA, Atlassian, and eTQ.
Ability to work and innovate in a fast-paced team environment while balancing business, compliance, and strategic needs.
Experience with Agile, Scrum, or 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 effectively prioritize efforts.
Ability to maintain compliance expertise and apply requirements to computer systems in ways that support business goals and maintain a compliant state.

Responsibilities

Manage and support implementation and maintenance of computer systems and software tools, such as eTQ and JAMA, used for QMS, SDLC, and design controls activities.
Evaluate user needs and recommend solutions and system configurations that support compliance and quality processes.
Define and manage user needs and support implementation execution.
Serve as a liaison with third-party system and tool vendors during and after implementation and when troubleshooting user-experience issues.
Facilitate system training and user acceptance testing (UAT), and scope proposed system enhancements.
Perform and support validation of regulated software applications, including testing and evaluation against design specifications and user requirements, in accordance with 21 CFR Part 11 and the organization's CSV process.
Work autonomously with related subject-matter experts on validation activities.
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 deliverables meet business and regulatory needs.
Drive and defend validation compliance with internal and external auditors, regulatory authorities, and other certified bodies.
Continuously improve and provide input into validation strategies for system and software-tool changes.
Promote quality risk management and risk-based approaches to CSV.
Ensure good documentation practices and assist with compliance documentation.
Write SOPs and other CSV deliverables as needed.
Train project teams on Tempus CSV standards and processes.
Support writing, review, and approval of Design History File (DHF) deliverables.
Support FMEA and risk-management activities in accordance with ISO 14971.