• Quality and Regulation Specialist

    Location IL-Rishon Le Zion
    Requisition ID
    # of Openings
    Quality & Regulatory
  • Overview

    RA/QA Specialist

    Job Responsibilities:

    Support the company’s Quality and Environmental Management Systems as follows:

    Audits - planning, participation and follow up of internal and external audits

    Training - delivery of basic QA/ Environmental and Compliance related training

    Document management - updating Quality manual, SOPs and work instructions

    Collection of quality related metrics, data analysis and reporting

    Assist with investigations into product or process failures

    Execute corrective actions (Product holds / release; customer communications)

    Provide input for Quality Management Review as required

    Ensure appropriate quality records are kept according to regulatory and company guidelines

    Participate in process improvements activities / projects

    Conduct process performance surveys and reporting on findings

    To undertake Quality and Regulatory related projects as required

    Provide general regulatory and quality support to the RA/QA department

    Support the RA/QA processes in software development

    Job Requirements:

    Knowledge and experience with Software Development processes

    Understanding of QA principles

    Experience in ISO procedures (9001, 900003, 62304), optionally medical device issues- an advantage

    Professional education in Industrial engineering or technical area

    Detail orientated and Strong communication skills

    High level of English - verbal and written

    Experience in a medical, regulated environment- an advantage



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