QARA Manager
hace 1 mes
Overview
Post Date January 12, Number WEBWW-- Job Function QA&RA Location Lliçà d'Amunt, Cataluña, España Country Spain
About the Position
We are looking for a QARA Manager responsible for supporting that company quality system is in compliance with applicable regulations, standards, internal procedures and best practices. The role will monitor and advise on the performance of the quality management system, produce data and report on performance. The role is responsible to support and facilitate the Regulatory Affairs activities to ensure that products comply and meet medical device regulatory requirements
Key Accountabilities:
Cooperating with the QA/RA Director to co-ordinate quality assurance activities. Maintaining Quality Management system procedures. Cooperating with different company departments for implementing quality system procedures. Supporting internal and external Quality System audits. Participating in the continuous improvement process of the Quality System and collaborating in the annual Quality System Management Review Supervising software development process assessments. Monitoring and advising on how the quality system is performing. Disseminating knowledge about the Quality System. Ensuring and providing quality system training to all employees. Cooperating with Corrective and Preventive actions management. Coordinating Certification Entity, Notified Body and/or Competent Authorities interactions. Cooperating in post-market surveillance activities and complaints management. Participating in the selection of the QA team members.Networking/Key relationships
To be determined based on department needs, to include interactions such as:
Interaction with the QA/RA Director to co-ordinate quality assurance activities Interaction with different company departments for implementing audit plans and give support and advice on quality and regulatory matters. Interaction with Suppliers, Affiliates and Distributors External interactions with Notified Bodies and Competent Authorities for product regulatory compliance.Education: Engineer, computer Science or other Technical carrier, or equivalent work
experience
