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.

Areas of Authority:

· 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

Participate in applicable forums and committees- COCO, Staff, SMC, PMS, QRB and others as required