Quality Assurance Specialist

hace 2 días

Barcelona, Barcelona, España Nobel Biocare A tiempo completo
Job Description

This role is to support the Quality Assurance and Regulatory Affairs function at Mimetis Biomaterials, a small medical device company located in Barcelona, Spain.

The Quality Assurance and Regulatory Affairs Specialist is accountable for ensuring the timely execution of quality activities and regulatory strategies to support launch activities and maintain compliance status for Mimetis Biomaterials products.

Key Responsibilities:
  • Support the set-up, maintenance, and documentation of the Quality Management System (QMS), including writing and updating Standard Operating Procedures (SOPs) and Work Instructions (WIs).
  • Ensure the effective implementation of internal procedures and processes.
  • Manage appropriate Quality Assurance processes, including Corrective Action Preventive Action (CAPA), Non-Conformities, Field Safety Corrective Actions (FSCA), Complaints, Document Control, and Change Control.
  • Define and implement Quality actions and trainings.
  • Support internal and external audits in the audit preparation and audit back office.
  • Support Medical Device registration/notification for class III products and technical documentation submission.
  • Support the execution of regulatory strategies for access to main markets, including the EU and US, and update product strategy based on regulatory changes.

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