QA Manager

תיאור משרה

? Manage and maintain the quality management system to meets all relevant regulatory requirements of ISO13485, MDR, FDA 21 CFR Part 820, and other applicable standards.
? Manage and lead the QA team, providing guidance, training, and hands on support.
? Determine and monitor quality KPI’s.
? Manage, develop and improve quality procedures and protocols, ensuring that they are effective, efficient, and in compliance with regulatory requirements.
? Ensure that all processes related to the manufacture, incoming inspection, release and distribution of products are documented, validated, and controlled.
? Conduct internal audits of the quality management system to ensure compliance with regulatory requirements and identify areas for improvement.
? Participate and prepare for external audits by Notified Body, FDA and other regulatory authorities.
? Supplier management including conduct of supplier audits, approval of suppliers, annual supplier evaluation and routine contact with suppliers.
? Responsible for data collection and trend analysis for the management review process
? Lead the corrective and preventive action (CAPA) process in the company, including investigations and follow up of effectiveness checks and trend analysis.
? Leads the MRB, NC, and calibration procedures.
? Complaint handling investigations
? Participates in process validation and re-validation activities
? Ensure that production and packaging operations, including sterilization are performed according to procedures.
? Participate in risk analysis activities