About Pi-Cardia
Pi-Cardia is a growth-stage medical device company focused on developing innovative solutions for structural heart disease. Founded in Israel, with expanding operations in the United States, Pi-Cardia combines clinical excellence, technological innovation, and entrepreneurial agility. Our team works closely with leading physicians and global partners to bring meaningful, life-improving therapies to patients worldwide. We are building a high-performance organization that balances rapid growth with operational discipline, regulatory excellence, and a strong people-first culture.
Position Overview
We are looking for an experienced Senior Quality Assurance Specialist to join our growing Quality team. In this role, you will help ensure the highest standards of quality and regulatory compliance across the product lifecycle of our innovative cardiovascular medical devices. Working closely with cross-functional teams, you will support product development, manufacturing, validation, and quality system activities, contributing to the successful delivery of safe and effective products to patients worldwide.
עיקרי התפקיד
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, manufacturing-related processes, validation activities, and change management processes.
Participate in the preparation, review, and maintenance of quality documentation such as procedures, work instructions, protocols, reports, and quality records.
Collaborate with cross-functional teams to support quality objectives, process improvements, manufacturing changes, and continuous improvement initiatives.
Support implementation, documentation, and follow-up of validation and quality-related change activities as required.
Support compliance with regulatory and quality standards, including ISO 13485 and applicable medical device regulations.
Participate in internal and external audits as needed.
דרישות
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, including risk management, design controls, validation activities, and manufacturing-related quality processes.
High attention to detail and strong organizational skills.
Ability to work both independently and as part of a team in a dynamic environment.
יתרון
Experience with change control processes and quality documentation — an
Strong written and verbal communication skills in English; Hebrew is an