דרושים אייסקיור מדיקל בע"מ

A global medical devices company in Caesarea is looking for a Quality Management System (QMS) team member.
* Develop equipment and software validations per ISO 13485/FDA 21 CFR part 820.
* Generate and review completeness of documents such as: drawings, SOPs, equipment and software validation protocols and reports.
* May perform or lead QMS or Design Assurance activities (e.g., document control, audits, receiving inspection, non-conforming product, ECO).

Application specialist R&D for international company.
Position Responsibilities:
User's controlled documents: Create user's manual, quick start manual, application & clinical related documentation.
Field support: Field issues diagnostic, Field issues diagnostic, Onsite and remote costumer support, Onsite training.
Clinical Study support: Assistance for IRB and ethics committee submissions, Assistance for clinical study related administrative tasks, Onsite training, and support.
Define usability plan document for technologists and physicians.
Implement usability plan and create report for regulatory approvals.