Quality Assurance Director will lead the QA team to ensure strict compliance with regulatory and quality standards for medical devices. This role involves close collaboration with cross-functional teams to support product development and expansion, while ensuring adherence to global regulatory requirements.

Key Responsibilities:
• Quality System Leadership
• Lead and manage the QA team to ensure ongoing compliance with QMS standards such as ISO 13485, EU MDR, GxP, FDA regulations, and MDSAP.
• Oversee internal audits, non-conformance management, CAPA processes, and customer complaints, driving timely and effective resolution of issues.
• Audit and Compliance Management
• Lead the preparation and management of external audits and implement corrective actions related to MDSAP, MDR, ISO, FDA, and other relevant regulatory bodies.
• Serve as the Person Responsible for Regulatory Compliance (PRRC), ensuring compliance with post-market surveillance, reporting obligations, and conformity assessments.
• Product Development Support
• Quality Improvement
• Training and Mentorship

Experience:
• Master’s degree or equivalent in a relevant field, with 8+ years of experience in quality assurance/control, including leadership roles within the medical device or diagnostics industry.
• In-depth knowledge of MDSAP, MDR, ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations.

Please send your CV to HR@FizeMedical.com