Director, Quality Assurance

About the role

The Director, Quality Assurance will lead the development, implementation, and management of quality systems and practices for Akura Medical’s medical device portfolio. This role ensures that product development, manufacturing, testing, and release meet all applicable federal, state, and international regulations as well as the company’s Quality Policy.

Key responsibilities

• Ensure compliance with FDA QSR, ISO 13485, MDR, GMP, and Design Controls.
• Partner with R&D and Operations to embed quality requirements throughout product development, transfer, manufacturing, and post‑market activities.
• Lead and maintain Design History Files, Risk Management Files, and related quality documentation.
• Develop and execute quality engineering activities such as design verification/validation, process validation, equipment qualification, test method validation, and first‑article inspections.
• Support manufacturing quality through inspection processes, non‑conformance investigations, CAPA, root‑cause analysis, and continuous improvement initiatives.
• Create and maintain manufacturing and quality documentation, including procedures, inspection instructions, lot history records, and bills of materials.
• Manage supplier quality activities, including qualification, audits, source inspections, and ongoing performance monitoring.
• Prepare for and host internal, customer, supplier, and regulatory audits and inspections.
• Coordinate quality system training and promote company‑wide awareness and compliance.
• Support complaint handling, MDR/vigilance reporting, field actions, and investigations of product or process failures.
• Represent quality on cross‑functional project teams and act as the site quality lead.

Required profile

• Proven experience ensuring compliance with FDA QSR, ISO 13485, MDR, GMP, and Design Controls.
• Strong background in leading design history and risk management documentation.
• Demonstrated ability to work collaboratively with R&D, Operations, and manufacturing teams.
• Experience managing supplier qualification and audit programs.

Required skills

• FDA QSR compliance
• ISO 13485
• MDR (Medical Device Regulation)
• GMP
• Design Controls
• Design History File (DHF) management
• Risk Management File management
• Design verification/validation
• Process validation
• Equipment qualification
• Test method validation
• First‑article inspection
• CAPA
• Root‑cause analysis
• Supplier qualification and audits