WILCO AG
Qualifizierungs- und Testingenieurin(m/w/x)
Full-time/Part-timeWith HomeofficeExperienced
Wohlen
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NDndd Medizintechnik AG
Junior Design Quality Specialist(m/w/x)
Zürich
Part-timeWith Home OfficeJunior
Nejo AI Summary
Supporting design quality, UDI, and product documentation for lung function testing devices. Bachelor's degree and 0-2 years in medical device quality management required. Flexible working hours, comprehensive onboarding.
Requirements
- Bachelor's degree in biomedical engineering, life science, or comparable technical/scientific field
- 0-2 years of professional experience in quality management, design quality, regulatory affairs, or regulated environment
- Exposure to documentation, labelling, translations, or product development in medical device industry
- Experience supporting coordination with internal teams and external service providers, including basic task tracking and follow-up actions
- Good communication and interpersonal skills, with ability to collaborate effectively in cross-functional teams
- Solid writing skills, with high attention to detail and accuracy when preparing and maintaining documentation
- Good knowledge of relevant standards (ISO 14971, IEC 62366, IEC 60601‑1)
- Very good user knowledge of documentation tools (MS Office, Polarion)
- Professional fluency in English and German; additional languages are a plus
Tasks
- Support design quality activities
- Coordinate labelling and translations
- Manage UDI activities
- Ensure product documentation accuracy
- Drive labelling activities for assigned products
- Coordinate translations of labels and manuals
- Perform verification for compliance
- Manage UDI assignment and updates
- Align UDI with labelling and documentation
- Support PMS and risk management
- Contribute to CAPA activities
- Maintain quality records
- Support audits as required
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- MS Office
- Polarion
Benefits
Flexible Working
- Flexible working hours
Other Benefits
- Comprehensive onboarding
Modern Equipment
- Professional and modern technology
Informal Culture
- Collegial and supportive working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ndd Medizintechnik AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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NDndd Medizintechnik AG
Junior Design Quality Specialist(m/w/x)
Zürich
Part-timeWith Home OfficeJunior
Nejo AI Summary
Supporting design quality, UDI, and product documentation for lung function testing devices. Bachelor's degree and 0-2 years in medical device quality management required. Flexible working hours, comprehensive onboarding.
Requirements
- Bachelor's degree in biomedical engineering, life science, or comparable technical/scientific field
- 0-2 years of professional experience in quality management, design quality, regulatory affairs, or regulated environment
- Exposure to documentation, labelling, translations, or product development in medical device industry
- Experience supporting coordination with internal teams and external service providers, including basic task tracking and follow-up actions
- Good communication and interpersonal skills, with ability to collaborate effectively in cross-functional teams
- Solid writing skills, with high attention to detail and accuracy when preparing and maintaining documentation
- Good knowledge of relevant standards (ISO 14971, IEC 62366, IEC 60601‑1)
- Very good user knowledge of documentation tools (MS Office, Polarion)
- Professional fluency in English and German; additional languages are a plus
Tasks
- Support design quality activities
- Coordinate labelling and translations
- Manage UDI activities
- Ensure product documentation accuracy
- Drive labelling activities for assigned products
- Coordinate translations of labels and manuals
- Perform verification for compliance
- Manage UDI assignment and updates
- Align UDI with labelling and documentation
- Support PMS and risk management
- Contribute to CAPA activities
- Maintain quality records
- Support audits as required
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- MS Office
- Polarion
Benefits
Flexible Working
- Flexible working hours
Other Benefits
- Comprehensive onboarding
Modern Equipment
- Professional and modern technology
Informal Culture
- Collegial and supportive working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ndd Medizintechnik AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
ndd Medizintechnik AG
Industry
Healthcare
Description
ndd Medizintechnik AG is a leading innovator in pulmonary function testing devices, improving early detection of chronic lung diseases with spirometry devices sold in over 100 countries.
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