Dein persönlicher KI-Karriere-Agent
Junior Design Quality Specialist(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Office
- Polarion
Benefits
Flexibles Arbeiten
- Flexible working hours
Sonstige Vorteile
- Comprehensive onboarding
Moderne Technikausstattung
- Professional and modern technology
Lockere Unternehmenskultur
- Collegial and supportive working environment
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Junior Design Quality Specialist(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Office
- Polarion
Benefits
Flexibles Arbeiten
- Flexible working hours
Sonstige Vorteile
- Comprehensive onboarding
Moderne Technikausstattung
- Professional and modern technology
Lockere Unternehmenskultur
- Collegial and supportive working environment
Über das Unternehmen
ndd Medizintechnik AG
Branche
Healthcare
Beschreibung
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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- WILCO AG
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