CRITICAL CATALYST
medical devices • cosmetics • food supplements • health services evaluation • health impact assement
2 - 10
Quality Assurance Officer - Medical Devices
November 10
CRITICAL CATALYST
medical devices • cosmetics • food supplements • health services evaluation • health impact assement
2 - 10
Description
• 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.
Requirements
• Qualified professionals (QNQ level 6-8) with Quality Management & Assurance experience (minimum 1 year) • Health Sciences or Biomedical Technology bachelor's degree or higher • English and Portuguese language proficiency • Proficient scientific writing skills • 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.
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