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, 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.

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, including risk management, design controls, validation activities, and manufacturing-related quality processes.
• Experience with change control processes and quality documentation- an advantage.
• 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.