Quality Assurance Specialist

hace 2 días


Barcelona, Barcelona, España Nobel Biocare A tiempo completo
Job Title: Junior Specialist Qa/Ra

Company: Nobel Biocare

Job Summary:
This role is to support the Quality Assurance and Regulatory Affairs team at Mimetis Biomaterials, a small medical device company located in Barcelona, Spain. The Quality Assurance and Regulatory Affairs Technician is accountable for timely execution of quality activities and regulatory strategies to support launch activities and maintain compliance status for Mimetis Biomaterials products.

Key Responsibilities:
1. 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).
2. Ensure the effective implementation of internal procedures and processes, including quality control and assurance activities.
3. Manage appropriate QA processes, including CAPA, Non-conformities, FSCA, Complaints, Document and Change control, etc.
4. Define and implement appropriate Quality actions and trainings.
5. Support internal and external audits, including audit preparation and audit back office activities.
6. Support Medical Device registration/notification – class III products and technical documentation submission.
7. Support execution of regulatory strategies for access to main markets EU, US, and update product strategy based on regulatory changes.

Requirements:
The ideal candidate will have a strong background in quality assurance and regulatory affairs, with experience in medical device compliance. Strong communication and organizational skills are essential for this role.

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