Junior Design Quality Specialist (50-60)
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Job Location:
Zürich - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Tasks
Labelling & Translations
UDI Management
Quality & Compliance Support
- Drive labelling activities for assigned products in line with regulatory and market requirements.
- Coordinate translations of labels operator manuals and software-related texts.
- Ensure accuracy consistency version control and timely implementation of updates.
- Perform verification activities to confirm compliance with defined requirements.
UDI Management
- Manage UDI activities for assigned products including assignment maintenance and database updates.
- Ensure alignment between UDI labelling and technical documentation.
- Support UDI-related changes across the product lifecycle.
Quality & Compliance Support
- Support PMS and risk management activities ensuring alignment with labelling and IFU content.
- Contribute to CAPA activities related to labelling UDI and product information.
- Maintain quality records and support audits as required.
About the position
Your key role is to support design quality activities and product integrity by coordinating labelling translations and UDI management. As a Junior Design Quality Specialist you contribute to essential quality and regulatory processes including Quality Management Risk Management Post-Market Surveillance and CAPA. You support the creation maintenance and accuracy of compliant product documentation and ensure it remains up to date throughout the entire product lifecycle in close collaboration with cross-functional teams. Do you want to help us to make lung function testing accessible to everyone everywhere and to improve the lives of millions of people with lung diseases Then you have come to the right place!
Your profile
- Bachelors degree in biomedical engineering life science discipline or comparable technical or scientific field.
- 0-2 years of professional experience in quality management design quality regulatory affairs or another regulated environment.
- Exposure to documentation labelling translations or product development activities within the medical device industry is an advantage
- Experience supporting coordination with internal teams and external service providers including basic task tracking and follow-up actions.
- Good communication and interpersonal skills with the 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 such as ISO 14971 IEC 62366 IEC 606011.
- Very good user knowledge of documentation tools (e.g. MS Office Polarion).
- Professional fluency in English and German; additional languages are a plus.
Why us
We offer an attractive location fair pay good social benefits flexible working hours hybrid work and the best conditions in which to do excellent work. This includes comprehensive onboarding professional and modern technology and a collegial and supportive working environment. We promote equal opportunities diversity and inclusion.
If this profile describes you and you would like to work at a fast-growing company in a global environment then we should meet. Apply directly and exclusively via our e-recruiting tool. The more we learn about you the better. We look forward to receiving your complete application and reference letters. Your data will be treated confidentially and discreetly.
If this profile describes you and you would like to work at a fast-growing company in a global environment then we should meet. Apply directly and exclusively via our e-recruiting tool. The more we learn about you the better. We look forward to receiving your complete application and reference letters. Your data will be treated confidentially and discreetly.
Contact
We kindly ask for direct applications only. Unsolicited dossiers from agencies will not be considered and we decline all responsibility for any fees related to such submissions.
About us
ndd Medizintechnik AG is a leading company and innovator in pulmonary function testing devices. For 30 years ndd has created solutions that improve early detection of chronic lung diseases including COPD and asthma. Today ndd offers unique spirometry and pulmonary function testing devices that are available in more than 100 countries around the globe.
Required Experience:
Junior IC
About Company
ndd Medizintechnik AG is a leading company and innovator in pulmonary function testing devices. For more than 25 years, ndd has created solutions that improve early detection of chronic lung diseases, including COPD and asthma. Today, ndd offers unique spirometry and pulmonary funct ... View more
