Quality Assurance Specialist

Sentinel Diagnostics; Milano; In loco; EUR 30.000 - 40.000; Tempo pieno

Descrizione del lavoro

A leader in diagnostic kit production is seeking a Quality Assurance Specialist to join their Quality Assurance Team. This full-time entry-level position in Milan involves managing quality system documentation, overseeing procedures, and ensuring compliance with ISO standards. Ideal candidates will have a scientific degree, relevant experience in the IVD/Medical Device sector, and strong teamwork skills. The role requires good English proficiency and knowledge of Office tools.

Competenze

• 4/5 years of experience in a similar role within the IVD / Medical Device sector.
• Good English knowledge (writing & speaking).

Mansioni

• Management of Quality System documentation according to ISO standards.
• Definition and review of procedures to support business processes.
• Management of non-conformities and internal deviations.

Conoscenze

Teamworking

Proactivity

Flexibility

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 in order to join the Quality Assurance Team is looking for a/an:

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 Body)

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

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Quality Assurance and Legal

Industries

• Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing

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