SARTORIUS STEDIM BIOTECH recrutement – Quality Manager – Ben Arous

Description de l’annonce:

German multinational company operating in the medical devices field is looking for a Quality Manager:

Main Responsibilities :

• Approval of the QMS documentation (ISO 9001 V 2015, ISO13485 V 2016)
• FAT (Factory Acceptance Tests) and SAT (Site Acceptance Tests) validation when purchasing machines, QI QO QP QD VMP (validation and preparation)
• Qualification, process validation, machines and management of equipment calibration
• DMP ECO ECR change management, process and product modifications
• Investigation and management of quality crises, complex problems (Quality tools, 8D RCA)
• Risk assessment (DFMEA – PFMEA – EFMEA with PLATEAU or Excel software, WSOT, 5M)
• SAP DMS and OPCENTER MES trainer and qualifying tasks
• Key user SAP: approval and validation of QM SAP access rights
• QM transactions Management of on stock, PMF (Workflow Product Master File) documentation and QM on SAP, RM and FP shelf lives
• KPI’s and operational quality performance indicators
• Digitization and implementation of electronic traceability EBR “Electronic Batch Record” MES (Manufacturing Execution System)
• Approval and management of process deviations from reprocessing and destruction protocols
• Leader for many projects (setting up MES – SAP – OUTSOURCING – MULTISOURCING – SMART CONSUMMABLE – PLASMA-SMART BR TREATMENT – ergonomic batch file)

Qualifications & Skills:

• Master’s degree in Science, Engineering or related field
• Participation in local or multinational projects 
• Minimum 8 years’ experience in related field similar position
• Excellent knowledge of methodologies of quality assurance and standards (relevant certification of quality control)
• Strong understanding of data analysis and statistical methods
• Excellent communication and presentation skills 
• Strong negotiation and leadership skills
• Critical thinker with problem-solving approach
• Pronounced sense of ownership; 
• Fluent in English

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