Operation Quality Manager

We are searching for an experienced and highly analytical Operation Quality Manager to join our Quality Assurance department to manage the Quality department in Operation. You will have a full responsibility for Process & Products quality in Operation to guarantee that all our products & Process meet quality and Regulatory compliance expectations and organization goals. To excel in this role, applicants should demonstrate great attention to details with excellent technical and interpersonal abilities.
Duties:
Responsible for quality in operations, implementing operational excellence methodologies and tools.
· Leading Manufacturing Quality Activities Defining goals, KPIs and plans to improve product quality.
· Supplier Quality including Supplier approval, Audits and ongoing monitor.
· Incoming goods receive.
· Managing quality events: NC, MRB, Investigation, lead RCA & CAPA activities
· Supporting to validation (V&V) activity for new products and change requests.
· Defining and implementing key company processes.
· Monitoring Operations for compliance with Regulatory & QMS requirements.
· Continuous improvements: by use of quality tools, statistical thinking and analysis.
· Managing QC department (4 employees)
Required Qualification:
· Quality Manager/Supervisor 2+ Years of relevant experience in Medical Device industries.
· Previous experience with Global regulatory requirements in Pharma/Medical industry such as: FDA (QSR) and EU MDD/MDR, ISO 13485 requirements, MDSAP, etc..
· CQE (Certified Quality Engineer) qualification – Preferred,
· PLM Experience – Preferred.
· Strong written/verbal communication skills in Hebrew & English
· Well organized, Highly motivated, and independent.
· Team player and collaborator.