Quality Director

Eitan Medical is a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We're looking for excellent QA Director to join our QA Team.

• Oversees the Quality team- Product Quality, QMS and Compliance of the company.
• Act as the Management Representative.
• Establish periodical Quality strategic plans.
• Act as a facilitator in External Audits in the Eitan Medical and Eitan Medical regional entities.
• Perform Internal and Supplier audits.
• Responsible for all company QMS related Internal training and qualification.
• Provide guidance to product development, Engineering, Ops., Service and RA teams as to the required deliverables to ensure compliance throughout product and QMS life cycle.
• Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements and any improvement needed.
• Responsible for compliance of the quality system, products, and services.
• Responsible for driving continuous improvements in the organization.
• Responsible for providing a process structure that incorporates quality points that become intrinsically linked to the process itself.
• Customers contact person with regards to Quality related matters.
  
  

• Review and approve Quality System related documentation and records.
• Review and support activities performed by applicable Quality personnel.
• Issue Audit reports
• Review and approve CAPA’s, NC, Audits