Quality Systems Specialist
We are an internationally successful and established company with 40 employees in Zurich and 20 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, which enables us to continually develop our technology and products.
You will be part of a motivated and engaged team in an international environment, which is guarantying that the processes required by the standard are in place and applied in the company. With your skills and commitment, you finally contribute to an Early Diagnosis for Better Lung Health for thousands of people.
If you recognize yourself in the profile, then we should meet! We are looking forward to receiving your application including a letter of motivation (English or German), curriculum vitae and job references by email to email@example.com. Your data will be handled confidentially and discreetly.
Direct applications are preferred; we do not accept profiles coming from recruiting partners for this role.
...ideally consists of the following tasks
- You maintain and continuously improve our quality management system, ensure compliance with applicable regulations (e.g. MDR, MDSAP). Furthermore, you collect, analyze and evaluate post-market surveillance data and ensure information sharing between stakeholders.
- You support our process owners/teams to establish and improve and apply assigned processes.
- As a proactive partner you collaborate with key internal stakeholders and support the QM user community to achieve and establish KPIs for an effective process management.
- You provide trainings on the QM system for all employees (onboardings / continuous improvement process).
- You manage CAPAs, NCMs and SCARs, assess vigilance, and initiate potential reporting. Furthermore, you are responsible for internal and external audits. You support the definition and implementation of remedial action and promote trending activities.
- You are responsible to compile and maintain clinical evaluation reports.
- You lead quality and clinical affairs projects, represent respective matters in multidisciplinary teams.
We are looking for a pro-active, open-minded, and engaged personality who has:
- A bachelor’s degree in Life sciences (or similar) and preferably experience in quality management in a medical devices industry with expertise in Clinical Affairs
- Strong knowledge of the global regulatory environment
- Experience in working in a multinational environment within the medical devices industry
- Excellent English- and German-Language skills (min. C1)
- Analytical thinking and scientific documentation skills; strong communication, organization and tracking skills
- Proficiency in MS Office and other relevant computer systems