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.
- 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.Β