Senior Quality Assurance Specialist

Pi-Cardia, a dynamic medical device startup specializing in cardiovascular innovations, is looking for an experienced Senior Quality Assurance Specialist to join our growing team. This role supports quality activities across product development, manufacturing transfer, and ongoing operations, and contributes to maintaining a robust and compliant Quality Management System.

Responsibilities:

• Support and maintain Quality Management System (QMS) processes in accordance with applicable regulations and standards.
• Contribute to quality activities across the product lifecycle, including development and manufacturing-related processes.
• Participate in the preparation, review, and maintenance of quality documentation such as procedures and work instructions.
• Collaborate with cross-functional teams to support quality objectives and continuous improvement.
• Support compliance with regulatory and quality standards, including ISO 13485.
• Participate in internal and external audits as needed.

Requirements:

• 5+ years of experience in Quality Assurance within the medical device industry.
• BSc in a relevant scientific or engineering discipline.
• Familiarity with medical device quality processes (e.g., risk management, design controls, manufacturing-related quality activities).
• Strong written and verbal communication skills in English; Hebrew is an advantage.
• High attention to detail and strong organizational skills.
• Ability to work both independently and as part of a team in a dynamic environment.