Quality Director
Obligāti:QA/TestSeniorLead
- Develop, implement, and manage the Quality Management System (QMS) to ensure compliance with industry standards and regulatory requirements, particularly in the medical supplies and disinfectants industry.
- Lead and manage the Quality Assurance (QA) and Quality Control (QC) teams, ensuring continuous improvement in quality performance.
- Establish and monitor quality KPIs to ensure product safety, reliability, and compliance.
- Manage ISO certification requirements, including documentation, periodic reviews, external audits, and renewal processes.
- Ensure compliance with applicable MDR requirements, including reviewing and maintaining Technical Documentation, coordinating compliance audits, and following up on audit findings.
- Prepare for and follow up on periodic inspections conducted by the Egyptian Drug Authority (EDA), ensuring regulatory compliance and timely closure of observations.
- Prepare, review, submit, and follow up on registration dossiers for medical supplies and disinfectants with the EDA and other relevant regulatory authorities.
- Maintain and update product registration files, technical documents, licenses, and quality records.
- Conduct internal and supplier audits, inspections, and risk assessments to ensure compliance with quality standards and procedures.
- Investigate customer complaints, quality issues, deviations, and non-conformities, ensuring effective implementation of Corrective and Preventive Actions (CAPA).
- Collaborate with different departments to implement quality standards throughout the product lifecycle.
- Develop employee training programs on quality standards, regulatory requirements, and procedures.
- Stay updated on ISO standards, MDR requirements, and EDA regulations.
- Report quality performance, audit results, and regulatory compliance status to senior management.
- Minimum of 7 to 10 years of progressive experience in quality management, preferably within the medical supplies and disinfectants manufacturing industry.
- Proven track record of leading Quality Assurance (QA) and Quality Control (QC) teams at a managerial level.
- In-depth knowledge of ISO standards, Quality Management Systems (QMS), and applicable regulatory requirements.
- Practical experience in ISO certification audits, MDR compliance reviews, and Technical Documentation.
- Hands-on experience dealing with Egyptian Drug Authority (EDA) inspections and regulatory requirements.
- Proven experience in preparing, reviewing, and following up on registration dossiers for medical supplies and disinfectants.
- Strong knowledge of quality assurance, quality control, risk management, and continuous improvement practices.
- Strong analytical and problem-solving skills, including root cause analysis and implementation of effective corrective and preventive actions (CAPA).
- Demonstrated experience in developing and implementing quality management systems and continuous improvement initiatives.
- Excellent leadership, communication, and interpersonal skills, with the ability to collaborate across different organizational levels.
- Ability to manage multiple priorities in a fast-paced, deadline-driven environment.
- Experience conducting internal, external, and supplier audits.
- Proficiency in quality management software and tools.
- Fluency in English; proficiency in Arabic is an asset.