Quality Assurance Specialist-medical device

Description

• • Manage and control Quality Management System (QMS) processes in general and specifically risk management, design controls and transfer to production activities.
• • Write, review and approve quality procedures and work instructions.
• • Collaborate with cross-functional teams to ensure quality standards throughout the product lifecycle.
• • Maintain a comprehensive understanding of quality and regulatory requirements, with a focus on ISO 13485 compliance.
• • Participate in external audits.
• Requirements
• • At least 5 years of relevant experience in a QA position within the medical device industry.
• • First degree in a relevant science or engineering subject.
• • Experience in risk management and design controls.
• • Excellent writing skills in English and Hebrew.
• • Demonstrate meticulous attention to detail in all QA-related tasks.
• • Work effectively under pressure to meet quality and project deadlines.
• • Strong teamwork skills to drive quality initiatives.
• • High ability to work independently.