Technical Designer responsible for maintaining technical documentation and supporting strategic direction at Novonesis. Involves 2D drafting in AutoCAD and quality assurance of documentation processes.
About the role
- Quality Assurance Engineer supporting the development of new medical devices at Coloplast. Engaging in design reviews, validation activities, and regulatory compliance in France.
Responsibilities
- Provide quality support for the development of new medical devices
- Participate in design reviews
- Verification/validation, risk analysis, and transfer to production
- Continuous improvement of the quality system, CAPA management, internal and external audits
- Review test protocols and associated test methods
- Support regulatory requirements and responses to regulatory queries
Requirements
- Engineering degree or master’s degree in biomedical engineering, with qualifications in quality assurance and quality control
- 3+ years’ experience in medical devices as a design assurance engineer
- Ability to work independently
- Good written and verbal communication skills in French and English
- Understanding of design controls, risk management, statistics, test method validation and new product development processes
- Knowledge of and compliance with FDA requirements and ISO 13485 and ISO 14971 standards
Benefits
- Onboarding within the French branch of an international market-leading group
- Stimulating and rewarding work environment
- Disability policy and quality-of-work-life (QWL) measures supporting integration and job retention
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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