Quality Assurance Specialist

Pi-Cardia, a dynamic medical device startup specializing in cardiovascular innovations, is looking for an experienced 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 the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulations.
• Participate in quality activities such as CAPAs, deviations, change control, complaints, and training records.
• Support quality aspects throughout the product lifecycle – from development through manufacturing and routine operations.
• Assist in writing, reviewing, and maintaining SOPs, work instructions, and quality documentation.
• Collaborate with cross-functional teams including R&D, Manufacturing, and Regulatory Affairs.
• Support internal and external audits as needed.

Requirements:

• 2–3 years of experience in Quality Assurance within the medical device industry (or other regulated industry).
• BSc in Engineering, Life Sciences, or a related field.
• Basic knowledge of ISO 13485, GMP, and QMS processes.
• Good written and verbal communication skills in English.
• Detail-oriented, organized, and able to work well in a team environment.
• Experience with Design Controls, CAPA management, or risk management- Advantages
• Experience working in a startup or medical device environment- Advantages