Senior Quality Engineer

RapidAI

. Establish, implement, and maintain software quality engineering processes across the complete SDLC in alignment with IEC 62304, ISO 13485, and FDA regulations .

Posted 11/4/2026full-timeGolden • Colorado • United StatesSenior💰 $95,000 - $115,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates expertise in software quality engineering processes aligned with IEC 62304, ISO 13485, and FDA regulations, with a strong focus on risk analysis, validation, and compliance within the medical device industry.

Highest-signal resume keywords

Software Quality EngineeringIEC 62304ISO 13485Risk AnalysisValidation & Verification (V&V)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software Requirements ReviewArchitecture SpecificationsTest Plans ReviewRisk DocumentationDesign History Files (DHF)Requirement Traceability Matrices (RTM)CAPA ManagementRoot Cause AnalysisAutomated TestingClinical Evaluation Deliverables

Soft Skills

Outstanding Communication SkillsAttention to DetailAccountability in CollaborationAbility to Thrive Under Pressure

Tools & Technologies

AWSCI/CD PipelinesAgile/ScrumJiraGitHubPropelTestRail

Certifications & Qualifications

ASQ CSQECQE

Industry Keywords

Medical DeviceDigital HealthLife SciencesFDA RegulationsISO 14971FDA 510(k)De NovoEU MDRQuality Management System (QMS)Software Tool Validation

Tech Stack

Tools & technologies

AWSSDLC

About the role

Key responsibilities & impact

Establish, implement, and maintain software quality engineering processes across the complete SDLC in alignment with IEC 62304, ISO 13485, and FDA regulations
Review software requirements, architecture specifications, and user stories for bidirectional traceability, objective testability, and risk mitigations
Drive product risk analysis under ISO 14971, identifying, mitigating, and verifying software hazards, failure modes, and risk controls
Review, audit, and approve software test plans, automated and manual test protocols, V&V execution reports, and clinical evaluation deliverables
Oversee software problem reports, anomalies, bug escalations, and non-conformances through root cause analysis, corrective actions, and verified closure
Support development, validation, and documentation of internal and third-party software testing tools
Serve as Quality Engineering liaison to R&D, Platform Engineering, Clinical Affairs, and Regulatory
Participate in internal audits, support FDA and Notified Body/MDR audits, and improve quality management procedures

Requirements

What you’ll need

5+ years of software quality engineering experience within the medical device, digital health, or life sciences industry
Bachelor of Science degree in Biomedical Engineering, Computer Science, Software Engineering, Electrical Engineering, or a related technical discipline
In-depth, hands-on working knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA 21 CFR Part 820 / QMSR
Experience managing design history files (DHF), requirement traceability matrices (RTM), risk documentation, and V&V reports
Experience managing software defects, CAPA, non-conformances, and root cause investigations
Outstanding written and verbal communication skills
Ability to hold cross-functional collaborators accountable to delivery milestones
Attention to detail and ability to thrive under tight sprint cycles and shifting priorities
Candidates must be currently authorized to work in the United States without restriction; visa sponsorship is not available
Preferred: Experience qualifying or testing AI/ML algorithms, computer vision pipelines, or diagnostic decision support software
Preferred: Familiarity with AWS, CI/CD automated validation pipelines, and Agile/Scrum
Preferred: Software Tool Validation under ISO/TR 80002-2 and ALM/QMS tools such as Jira, GitHub, Propel, or TestRail
Preferred: FDA 510(k), De Novo, or EU MDR submissions and external audits
Preferred: ASQ CSQE or CQE certification

Benefits

Comp & perks

Bonus
Equity
Hybrid work arrangement
Remote work on days not required in the office