Quality Engineer

vor 2 Wochen

Zürich, Zürich, Schweiz agap2 Switzerland Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

Agap2 is an European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what's behind closed doors of the biggest projects of our client's portfolio.

Responsibilities

We are looking for an engineer who will take responsibility for
quality performance and regulatory compliance in Medtech
manufacturing environments:

  • Ensure
    operational quality assurance
    on the production floor, including management of
    deviations
    ,
    CAPA
    ,
    root cause analysis
    and
    troubleshooting
    activities.
  • Evaluate and monitor
    supplier performance
    , lead
    audits
    , support
    inspections
    , manage quality
    agreements
    , and ensure
    raw materials
    and components meet required standards.
  • Oversee
    quality management system (QMS) activities
    , including procedure development, continuous improvement, KPI monitoring, and alignment with regulatory expectations (
    ISO 13485, GMP
    , etc.).
  • Lead
    risk management activities
    across manufacturing operations and propose pragmatic, efficient solutions to secure product quality and patient safety.
  • Act as a trusted quality partner from routine production support through
    scale-up,
    industrialization
    and
    lifecycle management
    of products.

Qualifications

  • Engineering degree or Master in quality, mechanical engineering, industrial engineering, or similar
  • Minimum 3 years of experience in the Medtech industry within manufacturing and quality functions
  • Strong knowledge of QMS principles and standards (ISO 13485, GMP)
  • Fluent in German and English
  • EU or Swiss citizenship

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