Software Quality Compliance Analyst

ABOUT US

Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics.

Our Mission: Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.

Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics.

For more information, please visit www.biodesix.com.

THE ROLE:

The Software Quality & Compliance Analyst I supports the verification and compliance of IT-developed and supported systems. This role assists with planning, executing, and documenting software verification deliverables in alignment with internal quality standards and external regulations (CLIA, CAP, ISO 13485, FDA 21 CFR Part 11). Works closely with senior analysts and cross-functional teams. The analyst helps maintain verified systems, supports change control, and promotes consistent, compliant practices across IT development, Security, AI, and IT Infrastructure projects. Our ideal candidate is detail-oriented, eager to learn and collaborative, with strong analytical and documentation skills in a regulated environment.

LOCATION:

On-Site in Louisville, CO

WHAT YOU'LL DO:

Software Verification & Compliance

• Support software verification activities for IT-developed and supported applications
• Organize and prepare verification plans, user requirements (URS), traceability matrices, test scripts, and summary reports
• Ensure verification deliverables meet regulatory and internal quality standards throughout the system lifecycle
• Participate in change-control processes by partnering with impact assessments, producing verification strategies, and coordinating testing and documentation
• Maintain the verified state of IT developed and supported systems through periodic reviews and documentation updates

Documentation Management

• Create, revise, and maintain IT-controlled quality and verification documentation that meets compliance requirements
• Translate complex software and technical requirements into clear, compliant, and user-friendly documentation
• Set up and maintain SOPs, templates, and work instructions related to software verification and lifecycle management
• Continuously improve documentation workflows, templates, and verification practices

Cross-Functional Collaboration

• Serve as a liaison between IT and Quality/Regulatory Affairs to align verification and documentation practices
• Partner with IT, QA, and operational teams to ensure project deliverables are completed, properly documented, and compliant with QMS expectations
• Promote a culture of quality and compliance within IT through training, collaboration, and process improvement

Audit & Regulatory Support

• Support internal and external audit by providing software verification records, change-control documentation, and related compliance evidence.
• Participate in CAPA investigations and reviews to ensure software governance aligns with HIPAA, ISO 13485, FDA 21 CFR Part 11, CLIA, and CAP standards.
• Support continuous readiness for regulatory inspection by maintaining accurate, audit-ready documentation.

Regulatory & Industry Awareness

• Stay current on evolving regulatory expectations and industry best practices related to software verification and quality systems.
• Apply risk-based decision-making and continuous improvement principles to ensure compliant and efficient verification and documentation processes.

WHAT YOU'LL BRING:

• 1–3 years’ experience in software or computer system verification, IT compliance, or quality systems in a regulated environment.
• Associate’s or Bachelor’s degree in Information Systems, Computer Science, or a related field, preferred.
• Strong analytical, problem-solving, and organizational skills.
• Excellent communication and teamwork abilities across IT and Quality.
• Familiarity with HIPAA, 21 CFR Part 11, CLIA, CAP, ISO 13485, or similar standards, preferred.
• Experience supporting software verification for regulated systems (LIMS, QMS, ERP, or custom applications), preferred.
• Skilled in writing clear, audit-ready documentation and reports.
• Proficient with tools such as Azure DevOps, Jira, Bugzilla, eQMS, SharePoint, or Confluence, preferred.
• Familiarity with risk-based verification, test planning, and audit-trail review.
• Ability to interpret complex technical requirements and translate them into clear verification documentation.

WHAT YOU'LL GET:

• Annual Compensation Range $60,000 to $67,700
• Discretionary Bonus opportunity
• Comprehensive health coverage: Medical, Dental, and Vision
• Insurance: Short/Long Term Disability and Life Insurance
• Financial benefits: 401(k), Flex Spending Account
• 120 hours of annual vacation
• 72 hours of paid sick time off
• 11 paid holidays 3 floating holidays
• Employee Assistance Program
• Voluntary Benefits
• Employee recognition program

Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.

Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.