Quality Assurance Associate

Pi-Cardia, a dynamic medical device startup specializing in cardiovascular innovations, is actively seeking a dedicated full-time Quality Assurance Associate. In this role, you will play a crucial part in supporting various QA functions across product development, transfer to manufacturing, and day-to-day operational activities.

Responsibilities:

• Collaborate with cross-functional teams to ensure quality standards throughout the product lifecycle.
• Support QA activities related to product development, manufacturing transfers, and ongoing operational processes.
• Manage and control Quality Management System (QMS) processes, including deviations, CAPA, complaints, changes, and training.
• Maintain a comprehensive understanding of quality and regulatory requirements, with a focus on ISO 13485 compliance.
• Demonstrate meticulous attention to detail in all QA-related tasks.
• Work effectively under pressure to meet quality and project deadlines.
• Exhibit assertiveness and strong teamwork skills to drive quality initiatives.

Requirements:

• 2-5 years of relevant experience in a QA position within the medical device industry.
• First degree in a relevant science or engineering subject.
• Proficiency in managing and controlling QMS processes, including deviations, CAPA, complaints, changes, and training.
• Thorough understanding of GMP and GDP requirements.
• Familiarity with technical drawings and specifications.
• High-level proficiency in English, both written and spoken.
• Excellent writing skills in English and Hebrew, including the ability to create specifications for quality control, MRB, SOPs, and quality records.
• Experience in design control and Design History File (DHF) is an advantage.
• Familiarity with manual or automated quality systems is advantageous.
• Strong computer skills.