ERT

  • Quality Engineer (f/m)

    Arbeitsort DE-BY-Estenfeld
    Arbeitszeit
    40
    Art
    Regular Full-Time
  • Übersicht

    eResearchTechnology (ERT) provides unparalleled service and reliable solutions with a common purpose - to ease the challenges of product safety and testing efforts while improving and saving lives. Our important work sets the industry standard. Our team provides proven scientific and regulatory leadership to biopharmaceutical and medical device companies around the world. Our global clients rely upon our expertise - across Cardiac Safety, Respiratory research, ePRO, and Consulting Solutions - to expedite their clinical research studies and empower them to make their expert decisions, more quickly and accurately, related to their product development and approval efforts.

     

    Our global company is growing. Our aim is to lead clinical studies to success and to make a contribution to public health.  We identify and reward great talent. We're refreshingly friendly and our teamwork is unrivaled.

     

    Join us at our location in Estenfeld near Würzburg (Germany) for the challenge as a

     

    Quality Engineer (f/m) 

     

    Basic Purpose:

     

    Ensure Product and Process compliance according to Medical Device and ICH guideline regards to Complaint - Handlying, CAPA - Management, Production & Supply Chain and Clinical Trial Services.

    Aufgaben

    • Participate in design control or study teams to provide input on necessary regulatory and quality requirements for design and study projects or changes.
    • Supervision and direction of quality assurance activities of all test departments in receiving inspection, production & process control and final inspection
    • Decision upon quality related measures before shipment of products and control execution of corrective measures.
    • Participate in Internal and external Quality Projects in R&D and Production to assure fulfillment of Quality and Regulatory requirements and ERT Operating Procedures and processes.
    • Organization and definition of all necessary inspections and testing techniques for the products in relationship with change management, complaint issues, final inspection and production engineering
    • Define and Implement Quality Procedures for Complaint Management, CAPA Management, Final Inspection and Change Management in agreement with supervisor.
    • Perform quality checks on design control, production and study related documentation.
    • Maintain and execute the change management process in accordance with standard corporate procedures
    • Compile change management, CAPA and complaint related KPI’s including statistical analysis and periodic reports.
    • Handling of change request, CAPA and complaint tasks
    • Provide Training to departments on quality regulations and quality processes.
    • Maintain customer complaint file

    OTHER DUTIES AND RESPONSIBILITIES: 

     

    • Support other departments in processing change requests, CAPA and complaints
    • Maintain the status of documents in design projects
    • Support article introduction during development projects
    • Communicate status of Changes, CAPAs and Complaints to other departments
    • Adapt Quality Processes to changes in R&D and Production Processes if necessary.
    • Knowledge of all quality core processes and products in other Business Lines (CS, eCOA, RT)

    Qualifikationen

    • Technical education (Master/Bachelor degree or equivalent) with preferred approx. 2 years working experience
    • Working experience in quality assurance department or design control projects preferred
    • Basic knowledge of 21CFR Part 11, 21 CFR 820, ISO 9001/13485, ICH E6 and/or other applicable regulatory standards.
    • Experience managing CAPA’s and complaints
    • Excellent skills in analyzing issues and processes
    • Team oriented with excellent communication and organizational skills.
    • MS Office applications,
    • German and English Fluent

     

    We look forward to receiving your application. Please indicate your salary expectations and your availability and send your application by using our ERT career page.

     

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