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Quality Assurance Expert for Medical Devices
3 weeks ago
We are seeking a skilled Quality Assurance expert to join our Clinical and Regulatory team. This role offers the opportunity to become an expert in all corners of our Quality Management System, involved in all stages of product development, and responsible for ensuring internal quality processes are well-oiled.
Key Responsibilities:- Collaborate with the development team on product release projects.
- Support other departments in design control activities.
- Lead risk analysis for new products, supported by the clinical and development team.
- Review and revise QMS procedures to ensure efficiency and effectiveness.
- Assist management in prioritizing regulatory approval activities based on strategy and market potential.
- Create and coordinate product submissions for developed devices.
- Provide training on QMS procedures.
- Participate in audits, both internal and external.
This dynamic role requires a strong attention to detail, ability to structure tasks efficiently, and excellent communication skills in English. The ideal candidate will have experience in quality assurance and/or regulatory affairs, knowledge of quality management systems and regulatory requirements within MDR and ISO 13485, and experience with Software as a Medical Device.
Requirements:- At least 1 year of experience in quality assurance and/or regulatory affairs.
- Mastery's degree in healthcare, medical, or life science.
- Excellent communication skills in English.
- Knowledge of quality management systems and regulatory requirements within MDR and ISO 13485.
- Experience with Software as a Medical Device.
You will be part of a cross-functional team in a dynamic environment with tight deadlines. We value integrity, transparency, and honesty, and strive to learn beyond the surface, engage with each other, and have fun while pursuing big ideas.
