Quality Management Engineer

    Andrew Alliance Published: July 24, 2018
    Location
    Geneva, Switzerland
    Job Type

    Description

    We are looking for a motivated individual, to work as an International Quality Management Engineer. The person will contribute by implementing and enforcing the company’s quality assurance practices, by ensuring in particular that the development, the product design and the manufacturing processes meet regulatory and customers’ requirements. The candidate will also ensure that the Quality Management System is properly deployed and operational in all our different sites.

    JOB DESCRIPTION

    • Participate in the deployment and take the leadership of the quality management system (QMS) and ensure regulatory compliance of Andrew Alliance company and product family;
    • Communicate and collaborate effectively with Andrew Alliance multidisciplinary team to sustain the QMS;
    • Plan, coordinate and prepare required documentation for products certification (EU, UL, …);
    • Evaluate the impact of product changes and regulatory changes in relation to the instrument’s performances, conformities, and certification;
    • Conduct the development of Product Risk Analysis;
    • Guarantee an effective surveillance to keep Andrew Alliance products on the latest Directives (Regulatory watch);
    • Ensure the compliance and execution of the following processes: Non-Conformity management, Change control, Document control, KPI, Personnel Training/Qualification;
    • Take the leadership of the internal and external audit as well as the audits done by third parties;
    • Continuous improvement and dynamic support of the Quality Assurance;
    • Collaborate in GxP Product Qualification Program.

    PROFILE/REQUIREMENTS

    • Bachelor or Master degree in area’s relevant for Quality Control (e.g. Engineering)
    • Work experience in the life sciences industry, preferably within QA/QC or GxP or medical devices development
    • Mastery of the ISO-9001:2015 standard
    • Understanding of ISO-14971 Risk Management standard and general Robotics norms and knowledge in the standard ISO-27001 is a good asset
    • Knowledge of Medical Device Quality Management Systems based on ISO-13485 and FDA Quality System Regulation is an asset
    • Excellent skills in communication and reporting, both in writing and oral
    • Good team player, analytical and persistent and able to work in a highly dynamic multidisciplinary environment
    • Base location: Geneva, Switzerland

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