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Senior QA

PI-Cardia
Full-time
On-site
Rehovot, Center District, Israel
Senior QA Engineer

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