Temp Medical Device Safety Specialist
Zimmer Biomet
Winterthur, Switzerland
vor 4 Tg.

Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare.

  • We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products;
  • spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

    We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues.

    Together with healthcare professionals, we help millions of people live better lives.

    For the European Headquarters, based in Winterthur (Switzerland), we are looking for a

    Medical Device Safety Specialist MDR 100% m / f (temporary until December 31, 2021)

    Your main responsibilities :

  • Create and update technical reviews, specifications and other documents for MDR related submission
  • Interpret technical drawings
  • Interpret biocompatibility data
  • Review and validate reusable device cleaning and sterilization
  • Perform toxicological and / or microbiological assessment of manufacturing materials
  • Review of Safety Data Sheets (SDS) and other information on manufacturing materials
  • Close communication with manufacturing materials suppliers
  • Coordinate of analytical testing
  • Assist in writing risk / benefit analyses
  • Close collaboration with cross-functional departments Research, Quality, Supplier Quality, Regulatory, and Manufacturing
  • Assist in writing benefit / risk analyses
  • Review and preparing procedures and documents required for MDR conformity
  • Your Qualifications and Experience :

  • Minimum educational requirement is a BSc degree in relevant scientific disciplines, such as microbiology, chemistry, toxicology or biology (preferred is an MSc degree).
  • An advanced degree or experience in the field of medical device safety (e.g. biocompatibility or industrial sterilization) is a plus.
  • Coordinating projects
  • Completing projects with challenging time lines
  • Understanding of the principles and requirements of current Good Manufacturing Practice (cGMP) an advantage
  • Basic knowledge of industry standards and regulations, especially MDR
  • Fluent in German and English (written and spoken); working knowledge of French is an advantage
  • Basic knowledge of industry standards and regulations especially MDR.
  • Demonstrates strong written and verbal communication skills
  • Likes to work meticulously on written documents
  • Demonstrates an ability to utilize resources efficiently
  • Travel Requirements :

    This dynamic Job position has a willingness to travel up to 5% worldwide.

    If you seize this opportunity, you will be able to develop your international experience and be a part of a great and truly global team.

    Zimmer offers a wide range of challenging career advancement opportunities and a dynamic work environment. We look forward to receiving your complete application through the following.

    For this position, we accept direct applications only.

    Frau Isabell Singer

    Human Resources Senior Generalist

    8404 Winterthur

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