Director of Quality Assurance

About the role

Akura Medical is seeking a Director of Quality Assurance to lead the development, implementation, and management of its quality systems. You will ensure that product development, manufacturing, testing, and release meet all regulatory, international, and internal standards.

Key responsibilities

• Maintain compliance with FDA QSR, ISO 13485, MDR, GMP, and Design Controls.
• Partner with R&D and Operations to embed quality requirements throughout product lifecycles.
• Lead and manage Design History Files, Risk Management Files, and related documentation.
• Oversee design verification/validation, process validation, equipment qualification, test method validation, and first‑article inspections.
• Support manufacturing quality activities, including inspections, non‑conformance investigations, CAPA, root‑cause analysis, and continuous improvement.
• Develop and maintain manufacturing and quality procedures, inspection instructions, Lot History Records, and Bills of Materials.
• Manage supplier quality programs, including qualification, audits, source inspections, and performance monitoring.
• Prepare for and host internal, customer, supplier, and regulatory audits.
• Coordinate quality system training and promote company‑wide awareness.
• Handle complaints, MDR/vigilance reporting, field actions, and product failure investigations.

Required profile

• Extensive experience in quality assurance within the medical device industry.
• Proven ability to lead cross‑functional teams and manage complex quality systems.
• Strong knowledge of regulatory requirements and international standards.

Required skills

• FDA QSR
• ISO 13485
• MDR
• GMP
• Design Controls

What we offer

• Opportunity to shape quality strategy for innovative VTE treatment technologies.
• Collaborative environment within a fast‑growing, venture‑backed company.
• Access to state‑of‑the‑art R&D and manufacturing facilities.