Principle Professional Quality
Core
Lead quality assurance and compliance for digital health solutions, overseeing design, development, post-market support, and regulatory readiness.
Role type
Principal Professional Quality (Quality Assurance Lead)
Builds
Core Dx Digital Health Solution products
Domain
Healthcare diagnostics / Digital health / Regulated medical devices
Required skills
Quality assurance, risk management, ISO 9001, ISO 27001, CAPA management, supplier quality, audit facilitation, change control, verification and validation
Preferred skills
Software engineering, Agile/Scrum, cybersecurity principles, secure software development, root cause analysis, global cross-functional leadership
Technologies
ISO 9001, ISO 27001, Agile, Scrum
Responsibilities
Lead quality assurance efforts throughout the product lifecycle; oversee key quality system processes including document control and nonconformance management; support post-market surveillance and customer feedback analysis; provide quality oversight of suppliers and contractors; facilitate internal, external, and regulatory audits; collaborate with global teams to harmonize quality processes.
Seniority
Principal, hands-on IC with strategic oversight
