Quality Assurance Manager

A well-established client of ours, forming part of global corporation, is searching for a Quality Assurance Manager to join their team. The chosen candidate will lead the local QA team and work closely with management to ensure that Quality projects, documentation, supplier quality manasgement, customer requirements and performance of the QMS are implemented, maintained and continuously improved. 

Responsibilities:

• The implementation, maintenance and improvement of the Quality Management system in line with applicable regulatory requirements.
• Reporting to top management on the effectiveness of the quality management system and any need for improvement.
• Support the preparations and upkeep of the Technical files for each product family in line with the EU requirements.
• Support the RA function in the registration process of medical devices in different countries and the plant’s technical file 
• Leading and supporting the internal audit process to ensure compliance to our quality management systems requirements.
• Lead the investigations on complaints and ensure resolution of quality related issues. Ensure that the complaint management system in Europe is followed and up to date.
• Ensure timely conclusion of monthly key process indicators to ensure timely review and communication as per corporate requirements.
• Perform Management review in line with European quality management systems procedures and corporate requirements.
• Support the continuous improvement process and ensure the training program and processes are in line with the Quality Culture.
• Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organisation.
• Manage the Quality management system audits conducted by the Notified body and Customers.
• Support the product development and product and process validations in the Malta operations.
• Ensure that the batch documentation pertaining to the Malta products is complete and conforming.
• Escalate any quality issue in house or on the Market place that need the urgent attention of the VP

Requirements

• Candidates must already be based in Malta, with the legal right to work in Malta
• Ability to write protocols, analyzes data, interpret results and write technical reports.
• Written and verbal communication skills and problem solving ability
• Candidates must possess excellent interpersonal, organisational and leadership skills

Education and Experience

• Degree in Engineering, Material Sciences, or equivalent is mandatory
• Basic knowledge in Microbiology and GMP requirements is a must
• Knowledge of DMAIC, CAPA and problem-solving techniques is a must
• At least 5 years experience in a similar role within a manufacturing environment
• Prior experience within the medical devices industry is a huge plus

Job Reference: VJ010