Quality Specialist / Project Manager

  • Location

    Münnerstadt , Germany

  • Sector:

    Quality

  • Salary:

    70,000EUR - 80,000EUR

  • Contact:

    Rebecca Stevens

  • Job ref:

    21225

Quality Engineer


Are you passionate about Quality and want to work with a highly international company, who are serving the medical device, pharmaceutical and pharma packaging industries across 56 countries?

Responsibilities

  • Represent quality within the project core team for new product development and sustaining (including labelling)
  • Development and implementation of the quality system throughout the entire product life cycle, especially development and implementation of design control and risk management processes and associated standard operation procedures and documents (beyond the very project) in ISO 13485 framework
  • Approval of technical documentation (e.g. test reports, test reports, design reviews, risk management files)
  • In cooperation with Regulatory, accountable for product compliance to standards and regulations
  • Approval of Risk management files, including evaluation for new and / or modified products and processes
  • Apply statistical methods and process/design excellence tools to establish the test plans and evaluate test data and processes
  • Provide understanding for medical device regulations to other disciplines, train peers on associated processes, practices and documents
  • Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing and Marketing
  • Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics, and compliance all times

Experience required
· 3-5 years+ of experience in the medical technology industry involved in development and/or production of complex medical devices
· Experience in device and quality processes
· Working knowledge of Design Controls, GMPs, QSR, 21 DFR 820, MDD, ISO 13485 and ISO 14971
· Experience with the standards of medical devices / ISO 13485 as well as with MDD, knowledge about MDR definitely appreciated
· Experience with quality tools and statistical programs such as Minitab, Risk Assessment (FMEA, FTA), Experimental Design (DOE) and Process Improvement (SPC)
· Audit experience
· Fluency in English and German
 


If you're interested in this position, please contact Hollie Barry for further details: hollie.barry@adaptivelifescience.com