Senior QA

Pi-Cardia, a dynamic medical device startup specializing in cardiovascular innovations, is actively seeking a dedicated full-time Quality Assurance Associate. In this role, you will play a crucial part in supporting various QA functions across product development, transfer to manufacturing, and day-to-day operational activities.

Reporting to Quality Assurance Director.

Responsibilities:

• 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.