Quality Assurance Specialist

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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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