Quality Assurance and Regulatory Compliance Specialist 80-100% (Barcelona)

OBJECTIVE AND MAIN TASK OF THE FUNCTION
Key role in supporting the implementation, maintenance, and improvement of the STAAR ISO 13485 and MDR 2017/745-based Quality Management System (QMS) at STAAR Spain. This position also provides regulatory support (as the back up) to ensure compliance with EU MDR 2017/745 and Spanish medical device regulations.

·Assist in designing, implementing, and maintaining the QMS

·Support the development and control of quality documentation, including SOPs, work instructions, forms, and records.

·Support qualification and management of suppliers providing service or products to STAAR Spain

·Support internal, supplier audits and prepare for external audits and inspections

·Lead, plan and ensure completion and documentation of trainings for STAAR Spain personnel on quality procedures and regulatory compliance

TASKS

7.1

·Assist in designing, implementing, and maintaining the QMS accor...