Remote QA Specialist MDR IVDR (1-Year)

SGS; Lisboa; Teletrabalho; EUR 32 000 - 46 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Flexible schedule

Remote work across Europe

Learning & development options

Resumo da oferta

SGS is seeking a Quality Assurance Officer (1 year maternity cover) with strong QA skills to maintain and improve the internal quality management system (NB 1639) for medical devices. The role involves updating documentation to comply with MDD/MDR/IVDR, managing records and Bizzmine communications, and ensuring alignment with global standards.

Remote across Europe with a valid work permit, the position reports to the Quality & Regulatory Manager, Business Assurance, and requires

Qualificações

• Strong QA background in medical devices or quality systems.
• Experience with GDP, MDD/MDR/IVDR and ISO 13485 knowledge is preferred.
• Fluent written and spoken English.

Responsabilidades

• Maintain NB 1639 internal quality management system.
• Update and maintain documents under MDD, MDR and IVDR schemes.
• Manage the IF database and collaborate on generic scheme documents.
• Publish documents on the SGS website; manage Bizzmine user communications.

Conhecimentos

QA management

GDP

CAPA management

Document control

MS Office

English fluency

Formação académica

Bachelor’s degree in Biomedical Sciences or similar

Descrição da oferta de emprego

SGS is seeking a Quality Assurance Officer (1 year maternity cover) with strong QA skills to maintain and improve the internal quality management system (NB 1639) for medical devices. The role involves updating documentation to comply with MDD/MDR/IVDR, managing records and Bizzmine communications, and ensuring alignment with global standards.

Remote across Europe with a valid work permit, the position reports to the Quality & Regulatory Manager, Business Assurance, and requires