Sr. QA Specialist

Position: Sr. QA Specialist

Eitan Medical is an international Medical Device company that develops and manufactures innovative medical equipment. Specifically, we develop infusion pumps and their related accessory products.

Job Description:

· supplier approval/disapproval including supplier maintenance and issuance of the Approved Supplier List.

· Leading the SCARS process including SCAR initiation, SCAR follow up, Supplier investigation approval including root cause analysis and SCAR closure.

· Leading the supplier audits process (including initial and surveillance audits) for critical suppliers, service centers, laboratories etc. by conducting on site / remote audits. Issuance and execution of the supplier audits plan including supplier audits follow up and supplier non-conformance follow up and response approval.

Support the execution of service agreements, quality agreements with suppliers and service centers.

· Leading the supplier score card process, including trending.

· Manage all training activities within the organization (scheduling, follow ups, etc.)

· Reviewing employee trainings records to ensure that employees have completed all required training prior to performing their jobs.

· Monitoring and reporting on all training activities.

· Responsible for the annual training plan creation and execution.

Direct manager: QA Manager

Requirements:

· Education:

o Practical Engineer/ B.Sc. in Quality/ Biomedical/ Biotechnology or similar or CQM / CQE.

· Job skills:

3- 5 years of relevant experience.
Good knowledge of ISO 9001, ISO 13485 and international standards.

o Knowledge and experience with quality processes.

o Experience in the field of Medical Devices - an advantage.

o Knowledge and experience in quality processes

· Computer skills:

o Good knowledge of MS-Office tools (Excel, Word, PP).

o Acquaintance with E-Document management systems.

o Knowledge of statistical based computer programs such as Excel and/or Minitab

· Language skills:

English and Hebrew – fluent.

· Personality:

Ability to evaluate, prioritize, organize, multitask and problem solving.
Ability to work in a team as well as independently