Quality Assurance Specialist

JD Sports Fashion; Milano; In loco; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading diagnostics firm in Milan is seeking a Quality Assurance Specialist to manage documentation conforming to ISO standards. The role requires a scientific degree and 4-5 years in a similar position within the IVD or medical device sector. Candidates should possess good English skills and proficiency in Office tools, with a focus on teamwork, proactivity, and flexibility. This is an excellent opportunity to join a dedicated Quality Assurance Team.

Competenze

• 4-5 years of experience in similar role within the IVD / medical device sector.

Mansioni

• Management of Quality System documentation according to ISO 9001 and ISO 13485 standards.
• Definition and review of procedures, SOPs and forms to support business processes.
• Management of non-conformities and internal or supplier deviations.
• Management of corrective and preventive actions (CAPA).
• Support during internal or external audits.

Conoscenze

Teamworking

Proactivity

Flexibility

Good English knowledge

Formazione

Scientific degree

Strumenti

Office Package

Descrizione del lavoro

Sentinel Diagnostics, leader in the development and production of IVD diagnostic kits for clinical chemistry, immunology and molecular diagnostics, chromatography, is looking for a Quality Assurance Specialist to join the Quality Assurance Team.

Quality Assurance Specialist

Responsibilities

• Management of Quality System documentation in accordance with ISO 9001 and ISO 13485 standards
• Definition and review of procedures, SOPs and forms to support business processes
• Management of non-conformities and internal or supplier deviations
• Management of corrective and preventive actions (CAPA)
• Management of Product Change Notification (PCN)
• Support during internal or external audits (from customers and competent authorities / certification bodies)

Requirements

• Scientific degree
• 4-5 years of experience in similar role within the IVD / medical device sector
• Good English knowledge (writing & speaking)
• Excellent knowledge of the Office Package
• Teamworking, proactivity, flexibility