Design Quality Specialist
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 function testing devices that are available in more than 100 countries around the globe.
About the position
Your key role is to ensure that the highest quality standards are met during the design and development phases of our high-end products by driving compliance with regulatory requirements, industry standards, and internal quality policies. Your excellent collaboration with cross-functional teams verifies that quality is embedded in the design process from conception through to commercialization. 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.
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.
Tasks
- Prepare and review design history files (DHF) to ensure compliance with FDA, ISO, and other regulatory requirements.
- Ensure that design control requirements are met.
- Conduct and document risk management activities in accordance with ISO 14971.
- Coordinate and perform usability engineering activities.
- Manage and define operator’s manual content; manage translations based on product, regulatory, or other changes; check output against requirements.
- Contribute to Risk Management, Vigilance, PMS, and Quality Management.
- Support internal and external audits related to design controls and quality management systems.
- Develop compliance surveillance activities to detect and prevent misconduct.
Your profile
- Bachelor's degree in biomedical engineering, Life Sciences, or related field, with work experience (2-3 years) in quality assurance or a similar area; medical device industry preferred.
- 1-2 years of experience in product development of medical devices and cloud-based products.
- Expertise in Usability Engineering and Risk Management, incl. standards IEC 62366 and ISO 14971, IEC 60601-1; other standards are a plus.
- Experience with design control processes.
- Excellent technical writing skills and precise working style.
- Practical experience in formative and summative usability testing.
- Experience with Compliance Management Systems.
- Strong team player with excellent communication and interpersonal skills.
- Professional language skills in English, verbally and written, are mandatory. Others such as German and Spanish are beneficial.
We are looking for passionate people who can easily identify with our company, who bring drive, expertise, and good vibes to our enterprise. People who appreciate the community and know that sharing talents and information to achieve common goals and objectives is the best way to develop.
8005 Zurich