Principal I – R&D Quality Assurance Engineer (Digital Health)

About the role

We are looking for a Principal I R&D Quality Assurance Engineer to provide QA oversight for Digital Health software tools and customer‑facing systems in a regulated environment. The role works closely with IT, development and business teams to ensure compliance with 21 CFR Part 11, GAMP, CSV/CSA, ISO 13485 and GxP expectations using an Agile delivery model.

Key responsibilities

• Provide QA oversight for Digital Health software tools and supporting infrastructure.
• Apply CSV and CSA risk‑based approaches to review validation and testing strategies.
• Perform GxP and impact assessments to define validation scope and testing needs.
• Assess and support change control activities, including risk impact assessments.
• Ensure systems remain in a validated state throughout their lifecycle.
• Integrate QA activities into Agile sprints and releases.
• Review requirements and user stories for quality, testability and traceability.
• Review and approve testing evidence, defect assessments and retesting outcomes.
• Collaborate with IT and development teams to support compliant system delivery.
• Support audit and inspection readiness and provide strategic guidance for post‑market activities.

Required profile

• Bachelor’s degree in engineering, computer science, life sciences or related field.
• 5+ years of experience in software QA or validation within a regulated environment.
• Experience with change control, impact assessments and GxP systems.
• Ability to work effectively with global, cross‑functional teams.

Required skills

• CSV (Computerized System Validation)
• CSA (Computer Software Assurance)
• 21 CFR Part 11 compliance
• GAMP methodology
• ISO 13485 knowledge
• GxP expectations
• Agile development practices
• Jira
• ServiceNow

What we offer

• Relocation assistance.