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Tempus AI

Senior Quality Engineer

Tempus AI

. Manage and support implementation and maintenance of QMS software and SDLC/design-controls tools, including eTQ and JAMA .

Posted 10/27/2026full-timeUnited StatesSenior💰 $110,000 - $165,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Management System (QMS) software implementation and maintenance, with a strong focus on compliance within the medical device industry. Proficient in managing user needs, facilitating training, and ensuring adherence to regulatory standards such as FDA QSR and ISO 13485.

Highest-signal resume keywords
Quality Management System (QMS) ImplementationComputer System Validation (CSV)FDA QSR ComplianceISO 13485 KnowledgeAgile/Scrum Methodology

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Computer System Validation (CSV)Quality Management System (QMS)Software Development Life Cycle (SDLC)Risk ManagementUser Acceptance Testing (UAT)Standard Operating Procedures (SOPs)Design ControlsFMEARegulatory ComplianceDocumentation Practices
Soft Skills
Excellent Communication SkillsOrganizational SkillsInterpersonal SkillsAdaptabilityProblem-Solving
Tools & Technologies
ETQJAMAJIRAAtlassianAgile Tools
Industry Keywords
Medical Device IndustryIVDFDA RegulationsISO 1497121 CFR Part 11

Tech Stack

Tools & technologies
SDLC

About the role

Key responsibilities & impact
  • Manage and support implementation and maintenance of QMS software and SDLC/design-controls tools, including eTQ and JAMA
  • Evaluate user needs and recommend compliant system configurations and solutions
  • Define and manage user needs and support implementation execution
  • Liaise with third-party system/tool vendors during and after implementation and while resolving user-experience issues
  • Facilitate system training, UAT testing, and scoping of proposed system enhancements
  • Perform and support computer system validation activities, including testing software tools and computer systems against design specifications and user requirements
  • Support software engineering teams as quality representative for development, testing, and implementation
  • Collaborate with software development teams to build compliance capabilities and requirements
  • Drive and defend validation compliance with auditors, regulatory authorities, and certified bodies
  • Ensure continuous improvement and validation strategy inputs for system and software-tool changes
  • Drive risk-based computer system validation using quality risk-management principles
  • Ensure good documentation practices and prepare required compliance documentation
  • Write SOPs and CSV deliverables as needed
  • Train project teams on Tempus CSV standards and processes
  • Support medical device software design controls, including DHF deliverables and FMEA/risk-management activities under ISO 14971
  • Report to the Senior Manager, Software Quality

Requirements

What you’ll need
  • 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 FDA QSR, ISO 13485, IEC 62304, ISO 14971, CSV, and 21 CFR Part 11
  • Experience with SDLC tools: JAMA, JIRA, Atlassian, and eTQ
  • Experience with Agile/Scrum/iterative software development methodology
  • Demonstrated ability to operate and innovate in a fast-paced environment, 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 apply compliance requirements in a computer systems environment supporting business goals and maintaining a compliant state

Benefits

Comp & perks
  • Incentive compensation may be offered
  • Restricted stock units may be offered
  • Medical and other benefits depending on the position