Director of Quality Assurance & Regulatory Excellence

Employment; Doha; On-site; QAR 360,000 - 420,000; Full time

Job summary

Akura Medical in Doha, Qatar, is seeking a senior Quality leader to develop, implement, and manage the company’s quality systems ensuring development, manufacturing, testing and release comply with FDA QSR, ISO 13485, MDR and related standards.

The role partners with R&D and Operations to maintain DHF, risk files, CAPA and continuous improvement, while coordinating audits and supplier quality programs to support regulatory compliance and product safety.

Qualifications

• 15+ years of Quality or Technical Management experience in medical devices.
• Solid knowledge of FDA QSR and international standards (MDR, ISO 13485).
• Ability to lead Design History Files and risk management activities.
• Experience with CAPA, root cause analysis and audits.

Responsibilities

• Ensure compliance with Quality System Regulations and standards (FDA QSR, ISO 13485, MDR, GMP).
• Lead and maintain DHF and Risk Management Files.
• Oversee quality documentation and supplier quality activities.
• Prepare for audits and inspections (internal, customer, regulatory).
• Lead QA resources and promote cross-functional quality culture.

Skills

Quality Systems

Regulatory Compliance

Risk Management

Design Controls

CAPA

Audits

Documentation

Education

Engineering degree

Masters in Engineering

Job description

Akura Medical in Doha, Qatar, is seeking a senior Quality leader to develop, implement, and manage the company’s quality systems ensuring development, manufacturing, testing and release comply with FDA QSR, ISO 13485, MDR and related standards.

The role partners with R&D and Operations to maintain DHF, risk files, CAPA and continuous improvement, while coordinating audits and supplier quality programs to support regulatory compliance and product safety.