Quality Assurance Specialist

Sentinel Diagnostics; Milano; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading IVD company is seeking a Quality Assurance Specialist to manage Quality System documentation per ISO standards. Responsibilities include defining procedures, managing non-conformities, and supporting audits. The role requires a scientific degree and 4-5 years of experience in the IVD/Medical Device sector. Ideal candidates should possess good English skills and proficiency in Office software. This is an entry-level, full-time position located in Milan, Lombardy.

Competenze

• 4/5 years of experience in a similar role within the IVD / Medical Device sector.

Mansioni

• Management of Quality System documentation according to ISO 9001 and ISO 13485.
• Definition and review of procedures, SOPs, and forms.
• 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

Excellent knowledge of the Office Package

Formazione

Scientific Degree

Descrizione del lavoro

Get AI-powered advice on this job and more exclusive features.

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

Referrals increase your chances of interviewing at Sentinel Diagnostics by 2x

Get notified about new Quality Assurance Specialist jobs in Milan, Lombardy, Italy.