QA/RA Engineer

We’re looking for a proactive QA/RA Engineer to ensure Hallura’s products and processes meet the highest international standards — including EU MDR, ISO 13485, and FDA 21 CFR Part 820. You’ll work closely with R&D, manufacturing, and operations to strengthen our Quality Management System (QMS) and support regulatory compliance as we scale globally.
What You’ll Do
• Implement and maintain QA processes across production and operations.
• Lead and support core QMS activities: NCs, CAPA, SCAR, and supplier quality management.
• Review and approve documentation to ensure compliance with QMS and regulatory standards.
• Drive continuous improvement initiatives and quality planning.
• Support regulatory submissions and audits.
• Collaborate with suppliers and internal teams to resolve quality issues.
• Conduct complaint investigations and perform batch releases as needed.

Why Join Us
• Be part of a mission-driven startup developing breakthrough medical technology.
• Work in a collaborative, quality-focused environment with room to grow.
• Make a real impact on patient outcomes and product excellence.
דרישות התפקיד
• BSc in Engineering or related field.
• 2–4 years of QA/RA or supplier quality experience in the medical device industry.
• Strong knowledge of ISO 13485, FDA, and EU MDR requirements.
• Experience in clean room or production environments — an advantage.
• Excellent communication skills, attention to detail, and a hands-on, can-do attitude.