Remote QA Specialist — Medical Devices QMS (1 Year)

SGS; Milano; In loco; EUR 55.000 - 70.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible schedule

Access SGS University and Campus

Multinational environment

Comprehensive benefits platform

Descrizione del lavoro

SGS is seeking a Quality Assurance Officer on a 1-year maternity cover to maintain the NB 1639 medical device internal quality management system across Europe. You will update documents under MDD, MDR and IVDR schemes and manage the Bizzmine QMS alongside the Global Medical Device team.

Based remotely across Europe, you will collaborate with the Quality & Regulatory Manager and other departments to ensure compliant documents, CAPA processes, and robust records, while supporting continuous

Competenze

• Bachelor's degree or higher in Biomedical Sciences or similar field.
• Significant work experience in a QA role with medical devices.
• Knowledge of MDR/IVDR, MDD and ISO 13485 is preferred.
• Fluent written and spoken English.
• Excellent documentation and GDP practices.

Mansioni

• Maintenance of the NB 1639 medical device internal quality management system.
• Update and maintain documents under the MDD, MDR and IVDR scheme.
• Manage the IF database and collaboration on scheme documents.
• Publish documents on the SGS website and maintain Bizzmine records.
• Provide technical support to all parts of the business.
• Release updated QMS documents in Bizzmine.
• Ensure training records are up to date and aid continuous improvement.

Conoscenze

Quality management systems

CAPA management

Document control

GDP

Detail oriented

Organizational skills

Written procedures

MS Office (Word, Excel, Outlook)

Fluent English

Team collaboration

Formazione

Bachelor’s degree in Biomedical Sciences or similar

Strumenti

Bizzmine

Descrizione del lavoro

SGS is seeking a Quality Assurance Officer on a 1-year maternity cover to maintain the NB 1639 medical device internal quality management system across Europe. You will update documents under MDD, MDR and IVDR schemes and manage the Bizzmine QMS alongside the Global Medical Device team.

Based remotely across Europe, you will collaborate with the Quality & Regulatory Manager and other departments to ensure compliant documents, CAPA processes, and robust records, while supporting continuous