Quality Manager

Role & responsibilities

• Preparation and maintenance of Technical Files of Blood Bagsas per MDR 2017/745, ISO 13485, ISO 14971, ISO 10993-1.
• To plan, establish, document, implement, maintain, and update a post-market surveillance system in a manner that is proportionate to the risk class III and appropriate for the Blood Bags. The post-market surveillance obligations shall be in compliance with Article 10(10) of the EU Regulation 2017/745 & other applicable standards.
• Design & development documentation.
• Preparation of Usability engineering protocol & reports.
• Risk Management of medical devices as ISO 14971.
• Preparation of general performance & safety records.
• Clinical evaluation & PMCF plan as per MDR & MEDDEV guidelines.
• Maintain product UDI listings in country-specific databases.
• Track and trend & report all reportable events, including serious/adverse incidents, field safety corrective actions etc.
• To lead, establish, maintain, and continually improve the Quality Management System (QMS) in accordance with ISO 13485:2016.
• Ensure timely preparation, review, and approval of APQRs (Annual Product Quality Review) as per
• standard procedures.
• conducting GMP trainings and all other QA related trainings to all employees.
• Ensure Self-Inspections/Internal Audits as per approved schedule, identify gaps, and ensure timely
• corrective actions.
• Oversee Supplier Qualification activities including supplier audits, review of questionnaires, and
• periodic performance evaluations.
• Review and approve all validation and qualification protocols and reports (process, cleaning,
• equipment, software, etc.) as per validation master plan.
• Handling of deviations, market complaints, CAPA, and change control.
• Responsible for product release