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המימד השלישי גיוס והשמה

QA/RA group manager


A leading QA services is looking for a  QA/RA group manager.
The group aims to provide best service in the Israeli market and to gain market share and profits according to the company business plan, and establish software validation and information security verification services according the relevant standards applicable to medical devices.
The services should complement synergistically existing and future company’s testing, certification and consulting services in order to provide a highly integrated one-stop solution to the customers. 
 Responsibilities of the role: 
  • • Oversee daily operations for the department.
  • • Ensure the creation and implementation of a strategy designed to grow the business department.
  • • Coordinate the development of key performance goals for functions and direct reports.
  • • Department general policy, future aims and goals
  • • Recruiting and training of staff.
  • • Department resource allocation and spending
  • • Creating and managing department budgets.
  • • Evaluating performance and productivity.
  • • Researching and identifying growth opportunities.
  • • Work in close cooperation with other company departments such as Sales, Business development

דרישות התפקיד

  • • Degree in biomedical field and Business Management or Masters in Business Administration or experience managing cost centers
  • • Good knowledge and/or experience in global quality assurance requirements and registration requirements, including: Quality Management Systems compliant with current ISO 13485, 21 CFR 820 and MDR/IVDR requirements.  
  • • MDSAP certification is a plus.
  • • FDA submissions, EU submissions, AMAR registration.
  • • Software QA requirements and processes.
  • • Familiar with global Cyber Security and Privacy requirements- advantage
  • • Good knowledge of different business functions in the Medical Devices field.
  • • Strong leadership qualities.

כישורים נדרשים