Quality Assurance Manager

Pi-Cardia, an innovative medical device scale-up specializing in cardiovascular solutions, is seeking an experienced QA Manager to join our growing Quality Assurance team. This role combines strategic leadership with hands-on quality oversight, supporting the full product lifecycle, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives. You will lead and develop a QA team, collaborating across functions to enhance product quality, process efficiency, and organizational growth.

Reporting to: QA Director

Responsibilities

• Lead, mentor, and develop a QA team, fostering a culture of quality and continuous improvement.
• Oversee quality assurance activities across product development and operational processes.
• Ensure compliance with the Quality Management System (QMS) and applicable regulatory standards.
• Review and approve quality documentation, ensuring accuracy and regulatory compliance.
• Partner with cross-functional teams to identify quality risks and implement effective solutions.
• Drive continuous improvement by analyzing workflows, identifying inefficiencies, and implementing corrective actions.
• Lead CAPA processes, including root cause analysis and preventive measures.
• Manage deviations and non-conformances, ensuring thorough investigation, documentation, and resolution.
• Support internal and external audits and regulatory inspections.
• Implement and enhance QA tools, metrics, and monitoring processes to support data-driven decision-making.

Requirements:

• 6+ years of experience in Quality Assurance within the medical device industry.
• BSc in a relevant scientific or engineering discipline.
• Experience in manufacturing and/or product development environments
• Proven experience leading or mentoring team members.
• Strong knowledge of quality processes in regulated environments.
• Excellent communication skills in English and Hebrew.
• High attention to detail and strong organizational skills.
• Ability to work both independently and collaboratively in a dynamic environment.