Design Quality Specialist with experience in Clinical Affairs
We are an internationally successful and established company with employees in Zurich and in Andover, USA. For more than 20 years, ndd Medizintechnik AG has created solutions that improve early detection of chronic lung diseases, including COPD and asthma. Today, ndd Medizintechnik AG offers unique spirometry and PFT device solutions that are available in more than 100 countries around the globe. We encourage innovation and teamwork, to enable constant development of our technology and products - which is becoming increasingly important in the field of pulmonary function diagnostics, not only due to COVID-19.To strengthen our Quality/CA/RA team located in Zurich, Switzerland, we are looking for an open-minded and self-driven personality as a Design Quality Specialist with experience in Clinical Affairs.
You will be part of a very competent and engaged team in an international environment. The key role of your job will be to contribute to the continued excellence of our lung function diagnostic devices, which must fulfill regulatory requirements with respect to safety and performance, as well as the expectations of our customers worldwide. We are offering good general conditions like 25 days paid holidays, good pension fund solution, part-time-workload, modern IT Infrastructure and more.
ndd Medizintechnik AG | Technoparkstrasse 1 | CH-8005 Zurich | Phone +41 44 512 65 53 | [email protected] | www.ndd.ch
If you recognize yourself in the profile, and you would like to work in a small company where you can help develop excellence, then we should meet! We are looking forward to receiving your application, including a motivation letter, your curriculum vitae and job references. Your data will be handled confidentially and discreetly. Please only use the apply button (via e-recruiting-system). Thank you!
Direct applications are preferred; we do only accept profiles coming from our preferred recruitment partners for this role.
- Manage Clinical Evaluation Activities, including establishment and maintenance of respective reports (SOTA, Clinical evaluation plan & report).
- Perform literature search, contribute to vigilance, PMS, risk management, clinical investigations.
- Coordinate and perform risk management activities for ndd products.
- Coordinate and perform usability engineering activities.
- Manage product label content and define operators manual content and manage translations, based on product or regulatory changes, market requirements or other triggers, verify outputs against requirements.
- University degree (M.Sc. or min. B.Sc.) in areas of biomedical engineering or life science discipline, with work experience (min. 3 years) in a Quality Management, Regulatory Affairs or Clinical Affairs role, in medical device/pulmonary function industry or appropriate service provider is strongly preferred.
- Minimum 2 years’ experience in product development of medical devices.
- Expertise in Risk Management and Usability Engineering, incl. standards ISO 14971 and IEC 62366, IEC 60601-1, other standards are a plus.
- Proven knowledge in systematic literature searching and medical technical writing.
- Experience in formative and summative testing
- Strong team player with a clear and concise communication style, verbally and writing.
- Advanced language skills in spoken and written English are mandatory, others like German/Spanish/Portuguese/Chinese are beneficial.