Remote QA Specialist, Medical Device QMS & MDR/IVDR

SGS; Madrid; A distancia; EUR 32.000 - 46.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible schedule

Descripción de la vacante

SGS is seeking a Quality Assurance Officer for a 1 year maternity cover. The role is remote-based, with candidates from across Europe who hold a valid work permit.

You will maintain NB 1639 internal quality management systems and support daily QA tasks across regulatory schemes such as MDD, MDR, and IVDR. You will manage document control, Bizzmine updates, and collaboration with global certification teams, while ensuring adherence to GDP and CAPA processes.

Formación

• Significant work experience in a QA role with exposure to medical devices or regulatory standards.
• Good knowledge of CAPA, document control, GDP and QMS processes.
• Fluent written and spoken English; strong communication skills.
• Ability to manage multiple tasks and support cross-functional teams across Europe.

Responsabilidades

• Manage complaints, compliance queries and appeals.
• Oversee continual improvement and document control within the QMS.
• Perform QA checks on updated QMS documents and release them in Bizzmine.
• Collaborate with Global Medical Device Certification teams and managers.
• Provide training records and support to the business as needed.
• Maintain knowledge of SGS procedures, regulations, and external criteria.

Conocimientos

CAPA management

Document control

GDP

Quality management systems

MS Office

Fluent English

Organizational skills

Teamwork

Procedures writing

Educación

Bachelor’s degree in Biomedical Sciences or similar

Herramientas

Bizzmine

Descripción del empleo

SGS is seeking a Quality Assurance Officer for a 1 year maternity cover. The role is remote-based, with candidates from across Europe who hold a valid work permit.

You will maintain NB 1639 internal quality management systems and support daily QA tasks across regulatory schemes such as MDD, MDR, and IVDR. You will manage document control, Bizzmine updates, and collaboration with global certification teams, while ensuring adherence to GDP and CAPA processes.