• Quality System Specialist

    Localisation SE-Sundbyberg | SE-Sundbyberg
    Identifiant de la demande
    Nombres de postes
    Qualité et réglementation
  • Présentation

    In alignment with European GCO strategic aims, manage the Quality and Environmental (where relevant) system for Benelux and Nordics Selling Organisation:

    - to ensure Sales business  is conducted in compliance with all applicable regulatory, quality and environmental requirements,

    - to promote best practices, to achieve organisational efficiencies, to ensure customer satisfaction and optimal value to the business.

    Be an active team member building European QMS


    Management of Quality and Environmental (where relevant) System

    Implementation and maintenance of Quality and Environmental Management Systems (e.g. ISO 9001, ISO 13485, ISO 14001) in accordance with European GCO strategy and Benelux and Nordics business needs.

    -              Pilot the quality documents process: Q&E manuals, SOPs and work instructions

    -              Conduct working groups to implement improvements into applicable procedures; follow-up their implementation and their efficiency with the appropriate indicators

    -              Responsible of the Quality and Environmental Management Review organisation with the local Managers : propose a Q&E policy related to the company objectives, change of organization , change of external regulations, lead the review and follow the realizations of the actions decided by the managers.

    -              Train newcomers and organize on a regular basis, refresh sessions on Q&E Management System

    -              Identify improvement opportunities by conducting internal audits and through the analysis of customer feedback data and KPI. Support the business to define corrective actions and improvement activities.

    -              Manage  external audits by regulatory bodies and customers

    -              Participate and assist in business risks management activities.

    Ensure that Quality and Regulatory obligations of  channel  partners are managed effectively

    Management of Customer Complaints

    -              Ensure that customer receive in a timely manner appropriate answers to their complaints

    -              Support local organizations in their reviews of issues raised by customers

    -              Provide oversight of the local customer complaint management process and optimize product quality feedback to Bio-Rad’s manufacturing divisions.

    -              Manage Field Actions according to Bio-Rad Global procedures

     Management of Regulatory Affairs

    -              Keep informed about regulatory changes for the different countries

    Ensure that the following activities are managed effectively in Nordics and Benelux :

    -              Critical records are maintained in compliance with company and regulatory requirements.

    -              Declaration for WEEE and others (lamps, batteries, packaging waste, chemicals) in a timely manner

    Involved in Benelux and Nordics projects according objectives (acquisition, new organisation, new system…)

    Active European QA/RA team member and get involved in projects according to objectives

    -              Participation to the internal European GCO audit program

    -              Involved in project according objectives to build & maintain the European QMS/ EMS


    Travels in Benelux, Nordics and UK

    Travels in Europe as GCO European team member


    Professional education in quality, regulatory & commercial areas


    Internal auditor, experience in ISO procedures (9001, 13485, 14001), optionally medical device issues


     Leadership skills, analytical (thinking) skills and solid decision making skills, independent working, accurate, flexible, proactive, communicative, team player, customer-oriented, ability to listen and to propose good sense decisions


    Fluent English language, either French, Dutch and/or Swedish as a native language


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