Quality Assurance Specialist

Sentinel Diagnostics; Milano; In loco; EUR 35.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading diagnostics company in Milan is seeking a Quality Assurance Specialist to manage documentation in compliance with ISO standards and handle deviations. The ideal candidate should have a scientific degree, 4-5 years of experience in the IVD/Medical Device sector, and strong English communication skills. This full-time position offers the opportunity to support audits and maintain quality assurance processes within an innovative environment.

Competenze

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

Mansioni

• 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 deviations.
• Management of corrective and preventive actions (CAPA).
• Support during internal or external audits.

Conoscenze

Good English knowledge (writing & speaking)

Proactivity

Flexibility

Teamworking

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 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