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BEBecton, Dickinson and Company

Quality Engineer – Medical Devices(m/w/x)

Vilters-Wangs
from CHF 145,775 / year
Full-timeOn-siteExperienced

Quality development for commercial production, including FMEAs and test method validation. 3+ years medical device industry experience, global regulations knowledge required; fluent German and English essential. Global project involvement in medical technology development.

Requirements

  • Bachelor's degree in engineering discipline
  • Practical knowledge of global regulations and standards for medical devices
  • At least 3 years of experience in medical device industry or similar regulated environment
  • Fluent in German and English
  • Good analytical skills
  • Process-oriented and high level of accuracy
  • Ability to work in multidisciplinary and international team
  • Knowledge of standard MS Office, especially Word
  • Knowledge of DOE and statistical software Minitab

Tasks

  • Support quality development activities for commercial production
  • Ensure compliance with quality system requirements and standards
  • Collaborate with Manufacturing Engineering on FMEAs and risk management documents
  • Assist in the validation and re-validation of test methods and processes
  • Develop, review, and approve protocols and reports for test method validation
  • Support the Manufacturing Engineering team with quality-related tasks
  • Conduct statistical analyses to determine process capability indicators
  • Assist in implementing process qualification and validation activities
  • Support corrective and preventive actions, including root cause analyses
  • Act as a quality expert during regulatory audits

Work Experience

  • 3 years

Education

  • Bachelor's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Tools & Technologies

  • MS Office
  • Minitab
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