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Quality Assurance Director
il y a 1 semaine
As a Quality Assurance Director at Guided Solutions, you will oversee and manage the quality assurance and quality control programs for our Class 3 medical devices.
This role ensures compliance with regulatory requirements, including FDA Quality System Regulations (QSR), ISO 13485 standards, and other global regulations and standards. You will lead the quality team in developing, implementing, and maintaining effective quality systems and processes to ensure the safety and efficacy of our medical devices.
- Key Responsibilities:
- Develop, implement, and maintain a robust quality management system (QMS) following FDA QSR, ISO 13485, and other applicable global regulations and standards.
- Ensure the QMS is consistently applied across all phases of product development, manufacturing, and distribution.
- Conduct periodic audits and assessments to evaluate the effectiveness of the QMS and identify areas for improvement.
- Maintain a thorough understanding of FDA regulations, ISO standards, and other applicable regulatory requirements for Class 3 and other medical devices.
- Establish and maintain comprehensive documentation systems, including device master records, design history files, and quality records.
- Develop and oversee risk management processes, including risk analysis, evaluation, and control measures.
- Investigate and manage non-conformances, complaints, and adverse events through an effective Corrective and Preventive Action (CAPA) system.
- Develop and deliver training programs to ensure all personnel are knowledgeable about quality practices and regulatory requirements.
