Salary
Not listed
Posted
4h ago
Work setup
Fully Remote
As Quality Assurance Officer, you will participate in the definition and implementation of Quality Management Systems (QMS) and preparation of Technical Documentation for MDs and SaMDs to be submitted to Notifying Bodies for CE marking purposes.
Baseline Profile
Qualified professionals (QNQ level 6-8) with Quality Management & Assurance experience (minimum 1 year) in developing and implementing Quality Management Systems according with ISO 9001, EN ISO 13485, EN 14971 and EN 62366
- Health Sciences or Biomedical Technology bachelor's degree or higher
- English and Portuguese language proficiency
- Proficient scientific writing skills
Highly Valued
- Solid knowledge of the regulatory framework applying to medical devices in the EU market
- Experience in the implementation of EN 62304 requirements within a Quality Management System
- Experience in the preparation of Technical Documentation for CE marking purposes of SaMDs
- Self-driven, self-organized and problem-solving oriented
Benefits
- Working in highly innovative products that can make a difference in people's lives.
- Positive and politics-free work culture built on the principles of lean and self-organisation
- Training, professional and personal skills continuous development
- Competitive salary and benefits
Our projects are mainly based in the European Union, United Kingdom and United States. We support self-management and cooperation, while respecting everyone's identity, beliefs and ideas. We strive to create a positive environment for our employees, supporting their professional growth and personal development.
CRITICAL CATALYST is a team of specialised consultants in regulatory affairs for the Medical Devices industry. We provide strategic counselling and tailored project management to ensure compliance with regulations and market access requirements for our client's products and services. Our mission is to create a clear path for businesses fast-forward through the global regulatory complexity.
Before you apply
- Confirm async-friendly culture vs daily standup-heavy expectations
- Ask about on-call rotation and incident expectations
- Check the tech stack matches what you actually want to use day-to-day
Interested in this role?
Apply on the original posting. No account required.
Listing via Himalayas
Quality Assurance Officer - Medical Devices (m/f)
CRITICAL CATALYST