.At Werfen in Clinical Software Business Unit we are committed to developing secure, efficient, and innovative clinical applications and laboratory instrumentation systems. Our solutions enhance patient care and facilitate the management of information in hospitals and laboratories around the world.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 requirementshttps://www.Werfen.Com/en/clinical-software-landingKey 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 systemprocedures.Supporting internal and external Quality System audits.Participating in the continuous improvement process of the Quality System andcollaborating in the annual Quality System Management ReviewSupervising 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 Authoritiesinteractions.Cooperating in post-market surveillance activities and complaints management.Participating in the selection of the QA team members.Networking/Key relationshipsTo be determined based on department needs, to include interactions such as:Interaction with the QA/RA Director to co-ordinate quality assurance activitiesInteraction with different company departments for implementing audit plans and givesupport and advice on quality and regulatory matters.Interaction with Suppliers, Affiliates and DistributorsExternal interactions with Notified Bodies and Competent Authorities for productregulatory compliance.Education: Engineer, computer Science or other Technical carrier, or equivalent workexperienceExperience:Minimum of 5 years of work experience in a Quality department, preferablywithin the Healthcare sector.Experience scheduling and performing internal audits and CAPAs managementExperience reviewing technical documentation and reportsExtensive knowledge of software medical device regulations and standardsReviewing standard operating procedures and work instructionsAble to detect improvement actionsSolid knowledge on international medical device regulations and standards (EUMedical Device regulations, CE Marking, FDA 820
