Director, Head of Quality Management System CDx
$180,000–$230,000 year
On-siteRedmond, Washington, United States
Job Summary
Establish, lead, and continuously improve a GMP-compliant Quality Management System for IHC-based Companion Diagnostics across development, validation, manufacturing, and post-market. Serve as the primary quality authority and management representative, ensuring full compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971 while governing the transition of assays from RUO/LDT to regulated IVD products. Own design control processes, risk management plans, and CAPA initiatives, acting as the main interface for FDA inspections, audits, and regulatory interactions. Partner with R&D, manufacturing, and clinical teams to embed quality-by-design and drive continuous improvement.
Required Qualifications
- Bachelor's degree
- Master's or PhD in Biomedical Engineering, Life Sciences, Pathology or related field
- 10+ years of quality experience in CDx, medical devices
- 5+ years in a senior quality leadership role
- Direct hands-on experience with FDA 21 CFR 820 implementation
- GMP systems
- ISO 13485 certification
- ISO 14971 risk management
- Proven experience supporting FDA inspections and regulatory audits
- Deep understanding of IVD/CDx regulatory pathways
- Strong leadership in design control and risk management
- Excellent inspection-management and communication skills
- Ability to influence across functions and senior leadership
- High integrity, accountability, and decision-making authority
Desired Qualifications
- Master's or PhD preferred in Biomedical Engineering, Life Sciences, Pathology or related field
- Experience supporting IHC-based diagnostics or pathology workflows
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