Remote QA Officer – Medical Device QMS Specialist

SGS Italia; Milano; Remote; EUR 45,000 - 65,000; Full time

Job summary

SGS is seeking a QA professional to maintain the NB 1639 medical device internal quality management system and handle daily QA tasks in line with MDD, MDR and IVDR requirements.

The role reports to the Quality & Regulatory Manager, Business Assurance. It is remote-based, open to candidates across Europe with valid work permits, and requires a Biomedical Sciences background and strong English skills.

Qualifications

• Bachelor’s degree in Biomedical Sciences or similar field.
• Experience in QA with medical devices or related sector.
• Knowledge of CAPA, document control and GDP.
• Fluent written and spoken English.
• Understanding MDR/IVDR, MDD and ISO 13485 is a plus.
• Ability to draft clear procedures and work in a team.

Responsibilities

• Maintain NB 1639 internal quality management system.
• Manage daily QA tasks: update MDD/MDR/IVDR docs and IF database.
• Publish documents on Bizzmine and SGS website; user communications.
• Collaborate with Global Medical Device teams and colleagues.
• Ensure training records are updated and support QC.
• Support development of combined scheme documents.

Skills

CAPA management

Document control

GDP

Detail oriented

Organisational skills

Workload management

Team collaboration

Procedures writing

MS Office

English proficiency

Education

Bachelor’s degree in Biomedical Sciences or similar

Tools

Word

Excel

Outlook

Job description

SGS is seeking a QA professional to maintain the NB 1639 medical device internal quality management system and handle daily QA tasks in line with MDD, MDR and IVDR requirements.

The role reports to the Quality & Regulatory Manager, Business Assurance. It is remote-based, open to candidates across Europe with valid work permits, and requires a Biomedical Sciences background and strong English skills.