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    Quality Senior Engineer - Courcelles, België - Randstad

    Randstad
    Randstad Courcelles, België

    2 weken geleden

    Randstad background
    Voltijd
    Beschrijving
    J&J Med Tech is recruiting for a Quality Senior Engineer to be located in Courcelles, Belgium.

    Key Responsibilities:
    Within the role, you will be responsible for the following processes:
    o QA Zone Owner: VAS area
    The "VAS area," where VAS stands for Value Added Services, is the dedicated space within the Distribution Center where all the repack and relabel activities take place. This is the hub of transformative actions where products undergo packaging modifications, labeling updates, or other value-enhancing processes to meet specific customer requirements, regulatory compliance, or marketing needs. In the VAS area, highly skilled and meticulous professionals work diligently to ensure precise execution of repackaging and relabeling tasks, guaranteeing the integrity, safety, and marketability of the medical devices. This dynamic space operates as a critical link between the manufacturing process and the final delivery to customers, adding value by customizing products and
    aligning them with unique market demands.
    o QMS SME: Change control

    As a member of our team, you will be accountable:
    o Deliver for Patients and Customer
    o Change control process
    o Drive a culture of continuous improvement
    o Audit readiness and certification
    o Strengthen the compliance of the site by effective change control management and assuring new changes are optimally, timely and compliantly implemented. Evaluate and ensure accurate documentation of applicable quality records and approve accordingly.
    o Get encouraged and activated by supporting project team activities and guiding them towards compliant project execution.
    o Broaden your network by the involvement in all Med Tech portfolio. Collaborate with peers in other parts of the EMEA commercial quality organization to improve process excellence, simplification, and standardization across distribution sites.

    ervaring

    <1 jaar

    jouw aanbod

    Qualifications:
    A minimum of a Bachelor's degree in Science, Engineering or other technical field is required. A Master of Science or in Engineer degree is preferred.

    Experience and Skills required:
    o 4-7 years QA related experience within an operational pharmaceutical or Medical Devices environment
    o Good knowledge in QMS system process (document management, change control, non-conformance, CAPA, standards assessments)
    o Knowledge of GMP/GDP/ISO 13485 regulations
    o Fluent in French & English
    o Ability to prioritize tasks and work independently
    o Embedded in shopfloor activities
    o Pragmatic
    o Problem-solving skills
    o Good communication
    o Agility invested in good collaborations with multiple partners, focus to details
    o Experience with digital solutions such as EtQ, Trackwise, Qlik, SAP for the management of Quality Systems against on the basis of disability

    opleiding

  • Professionele bachelor
  • Academische bachelor
  • Master
    ons aanbodYou will join an effective and open team. Together we support the Commercial Quality & Compliance of one of the main EMEA operational distribution center which supply products of our 3 business units in orthopedic, cardio-vascular and Surgery to worldwide customers. We value communication, clear sense of purpose, supporting business and good understanding of customer's expectations. You will work in line with Credo Values, Supply Chain and J&J Deliver Requirements.
    The position is based within European Distribution Center at Courcelles, allowing to be exposed to the operational environment and responsible for QA operational activities such as shop-floor investigation & inspections and continuous improvement. Every team member acts as a single point of contact for an operational area (QA Zone owner) and supports the area for all quality related topics (eg. Gemba-walk, CAPA, auditing, ..). As Quality team, we develop and deploy effective and efficient quality processes that meet customer needs and applicable J&J & Health Authority compliance requirements to support our growth.
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