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Quality Assurance Manager

CDI
Paris
Salaire : Non spécifié
Début : 05 juillet 2022
Télétravail fréquent
Expérience : > 4 ans
Éducation : Bac +3

Depixus
Depixus

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Le poste

Descriptif du poste

Description  
 
As we are approaching the launch of our instrument system as well as the associated sample preparation kits and reagents, we are currently looking for a QA/regulatory representative to implement the quality system of the company.  
  
As a Quality assurance and regulatory manager at Depixus, you will:  
·       Design & implement the quality policy 
·       Liaise with department representatives 
·       Implement and support quality management system (QMS/GED)  
·       Train team members to the use of the system and encourage good practices 
·       Redact and keep updated high quality documentation in constant connection with the appropriate teams and across teams 
·       Implement and follow up deviation, CAPA and change control 
·       Ensure regulatory requirements are followed 
·       Keep up to date to the latest regulatory requirements or guidelines relevant to the field 
·       Participate in the risk analysis as well as the implementation of actions to mitigate these risks 
·       Establish internal audits for product fabrication 
·       Review and approve the future products release (RUO kits) 
·       Review and approve documentations intended to customers 


Profil recherché

This role would suit you if you:    
·       At least 5 years of relevant experience in Quality Management 
·       Demonstrate good organisational skills  
·       Have sharp attention to details 
·       Have knowledge of using a QMS  
·       Have knowledge and experience in the regulatory landscape of RUO kits (Experience with regulation around CE—IVD kit production will be seen as favourable), experience in reagents would be appreciated 
·       Have good interpersonal and communication skills allowing to support the implementation of the quality management system across various department and sites 
·       Integrity, critical and analytical thinking, cooperation, team spirit and proactivity are essential 
·       Able to communicate in English and French, both in writing and orally 
·       Enjoy working in a dynamic start-up environment  
 
Recruitment process  
·                 Visio interview with the HR team  
·                 Technical test 
·                 Technical interview 
·                 Final interview on site 

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