Quality Assurance Manager

Quality Manager, R&D & OperationsLocation: Seattle, WA (Onsite)Reports to: Executive LeadershipCompensation: Base salary range $125K-$155K DOE Role OverviewAs a critical leader in a high-growth IVD medical device company, you will scale and manage a robust Quality Management System (QMS) compliant with ISO 13485, MDSAP, and EU MDR. This role combines hands-on QMS ownership with the leadership and mentorship of a dedicated Quality team.Key ResponsibilitiesTeam Leadership: Lead, coach, and mentor direct reports to foster a culture of accountability and continuous improvement.QMS Ownership: Define, implement, and scale the QMS in compliance with FDA 21 CFR 820 and ISO 13485.Quality Events: Manage and trend deviations, nonconformances, CAPAs, and complaints; ensure effective root cause analysis.Audit Management: Lead internal, supplier, and external audits (ISO/FDA); drive inspection readiness and remediation.Compliance & Documentation: Author and maintain SOPs, oversee document/change control, and serve as the eQMS owner.Operational Support: Oversee supplier quality and Contract Manufacturing Organizations (CMOs).QualificationsEducation: Bachelor's degree in science, engineering, or a related field.Experience: 6-9 years in Quality Systems within a regulated medical device or IVD environment.Leadership: Proven track record of managing and developing direct reports.Technical Knowledge: Deep expertise in ISO 13485, 21 CFR 820, and ISO 14971.Systems: Proficiency with GMP-compliant electronic systems (eQMS).Travel: Ability to travel up to 20% to supplier and CMO sites.Preferred CredentialsASQ Certified Quality Auditor (CQA)Regulatory Affairs Certification (RAC)

Created: 2026-05-08