Entreprise:
Entreprise Anonyme
Secteur: santé / paramédical / optique
Taille: Plus de 500 employés
Secteur: santé / paramédical / optique
Taille: Plus de 500 employés
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