QA SHIS Technician – Medical Device Systems

• High level of English (speaking and writing)

Reporting to the Quality Assurance - Systems Manager of the department, this person will be assigned the following functions:

• Participate in the definition, implementation, and improvement of the Synthon Hispania quality system for medical devices
• Maintain the GXP/medical device documentation system in both electronic and paper format when required
• Provide the necessary support in the release of medical device batches
• Provide the necessary support in medical device complaints
• Provide the necessary support in the preparation of medical device Product Quality Reviews
• Support and leadership, where appropriate, of audits received from customers
• Support in Inspections received from Health Authorities or Notified Bodies
• Drafting of the Quality Manual
• Provide the necessary support in the preparation of the Management Review
• Management of medical device training
• Management and review of quality KPI calculations.
• Support to RA for the updating of dossiers and product launches.
• Drafting procedures and reports, as well as assessing deviations from established quality standards and change controls for medical devices
• Participate in validation groups for facilities, utilities, equipment, or production processes related to medical devices
• Implement the regulations and documentation required by the system in the most pragmatic way possible
• Manage the projects assigned to them, and provide the necessary support in multidisciplinary projects
• Guarantee the adequacy of developed processes through self-inspections, internal audits, and supplier audits
• Know and comply with regulations related to Medical Devices