סקירה כללית
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.
דרישות המשרה
, 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
