Design Quality Specialist
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.
About the company
Zürich / Zurich
