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Quality Engineer – Medical Devices(m/w/x)
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
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
- Minitab
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Quality Engineer – Medical Devices(m/w/x)
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
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
- Minitab
About the Company
Becton, Dickinson and Company
Industry
Healthcare
Description
The company is a global leader in medical technology, advancing health through innovation in medical discovery, diagnostics, and care delivery.
Not a perfect match?
- Becton, Dickinson and Company
Manufacturing Engineer(m/w/x)
Full-timeOn-siteExperiencedVilters-Wangsfrom CHF 145,775 / year - 223 TCH - TRUMPF Schweiz AG
Supplier Quality Manager (SQM) im strategischen Einkauf(m/w/x)
Full-timeOn-siteSeniorGrüsch - Hamilton Bonaduz AG
Electrical Engineer(m/w/x)
Full-timeOn-siteExperiencedEms - Hamilton Bonaduz AG
Electrical Engineer im Product Care(m/w/x)
Full-timeOn-siteExperiencedEms - Körber Pharma Packaging AG
Automation Engineer Assembly / Labelling(m/w/x)
Full-timeOn-siteExperiencedGrabs