Senior Quality Manager
Core
Strategic and operational leadership for the Quality organization, ensuring patient safety, regulatory compliance, and continuous improvement across the product lifecycle.
Role type
Senior Quality Manager (Site QA Head designee)
Builds
Quality Management System (QMS), risk management frameworks, and audit-ready processes
Domain
Medical device manufacturing / Regulatory Quality
Required skills
Quality strategy definition, QMS effectiveness, internal/external quality escalations, data trending and signal detection, audit readiness, team leadership and mentoring, regulatory compliance execution
Preferred skills
Master's degree in engineering or Life Sciences, experience in leadership roles within QA/QC
Technologies
FDA 21 CFR Part 820/11, ISO 13485
Responsibilities
Define and execute site Quality strategy aligned with business objectives; Ensure effectiveness and compliance of the Quality Management System (QMS); Drive internal and external quality escalations with structured problem-solving; Utilize data trending to proactively identify risks; Strengthen systems for audit readiness; Lead, mentor, and develop the Quality organization
Seniority
Senior, hands-on IC with leadership responsibilities