Director, Quality
Core
Lead the Quality function and QMS for a medical device/life science tool company, ensuring compliance with ISO 13485 and FDA regulations while scaling quality systems for research-use products.
Role type
Senior IC Director of Quality (Medical Devices/IVD)
Builds
Scalable Quality Management System (QMS) and compliant product/process quality for research-use genomics tools
Domain
Medical Devices / In Vitro Diagnostics (IVD) / Life Science Tools
Required skills
ISO 13485 QMS leadership, FDA quality system requirements, risk management (ISO 14971), CAPA, supplier quality management, audit readiness, design controls, change control, executive communication
Preferred skills
Advanced degree in engineering/life sciences, experience with complex instrumentation/NGD/SaMD, ASQ certifications (CQE/CQA/CMQ/OE)
Technologies
ISO 13485, FDA QSR, ISO 14971, CAPA, Change Control, Supplier Quality Systems
Responsibilities
Establish Quality strategy and policies; Serve as Management Representative for ISO 13485 QMS; Lead supplier qualification, audits, and risk classification; Manage regulatory inspections and external audits; Drive continuous improvement and cross-functional partnership; Build and develop the Quality organization
Seniority
Director, strategic leadership & organization building