Head of Quality Assurance

Responsibilities:

• Providesupport to all departments in the company on quality assurance aspects.
• Initiate and implement of quality procedures and other controlled documents, including update, maintenance and protection.
• Prepare quality policy and quality manual.
• Maintain quality documentation: controlled documents log, DHF (design history file), DMR (device master record), MDF (medical device file)
• Work with certification authorities to maintain company’s ISO
• 13485/ MDSAP/CE MDR certification. Prepare company for external audits.
• Initiate and mange document change controls (DCO) and engineering change controls (ECO);
• Plan and conduct periodic internal quality audits.
• Provide support on validations and verifications activities and documentation.
• Perform annual trainings to all employees on quality aspects, as needed, perform trainings whenever new procedures are implemented and whenever procedures are updated.
• Assess training/ qualification needs to apply and monitor training programs. Maintain the list of trainings for each employee.
• Handle CAPA (corrective and preventive actions) on identified problems in all field of the company.
• Participate in the supplier selection process. Periodic evaluations of supplier’s performances. Conduct supplier audits (if needed)
• Handle customer complaint and reporting to the authorities.
• Handle nonconforming products / materials and MRB (Material Review Board) processes.
• Handle product recalls and field actions
• Approve batch records, release products to market and incoming materials.
• Approve labeling before printing.
• Prepare quality agreements or distributors and suppliers.
• Manage the process of rejected materials.
• Prepare and lead audits at PLM companies’ sites.
• Compile quality information needed for the management review.