Quality System Leader - Remote

Overview

The Quality System Leader is responsible for overseeing and maintaining the Quality Management System (QMS) to ensure compliance with medical device regulations and standards, leading the Quality System team.

In Short

• Maintain quality management systems based on ISO 13485 and corporate standards.
• Ensure compliance with EU MDR and FDA regulations.
• Develop and maintain quality processes and documentation.
• Act as the primary quality representative for regulatory audits.
• Oversee internal and external quality audits.
• Train and coach associates on QMS processes.
• Collaborate with cross-functional teams and external providers.
• Report on quality issues and trends to management.
• Manage multiple projects and prioritize tasks effectively.
• Work in a fast-paced and dynamic environment.

Requirements

• BS/MS in Engineering or relevant Life Science discipline.
• 5+ years of experience in a similar position.
• 10+ years in a manufacturing environment in the medical device industry.
• Experience in quality auditing.
• Fluent in Hungarian and English.
• Strong leadership and communication skills.
• Proficiency in data analysis and quality metrics reporting.
• GMP and ISO 13485 knowledge is a plus.

Benefits

• Opportunity to work in a leading global medical technology company.
• Collaborate on innovative solutions in healthcare.
• Be part of a mission to improve human health.
• Work in a dynamic and fast-paced environment.
• Access to cutting-edge research and technology.