Quality Assurance Director
The 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
• Collaborate with cross-functional teams to support product development and expansion.
Quality Improvement
• Identify and implement quality improvements to ensure ongoing compliance with regulatory requirements.
Training and Mentorship
• Provide training and mentorship to the QA team to ensure they have the necessary skills and knowledge to perform their roles effectively.
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.
Contact Information
Please send your CV to HR@FizeMedical.com