Quality System Leader

Job Description Summary

The Quality System Leader is responsible for overseeing and maintaining the Quality Management System (QMS) to ensure compliance with medical device regulations and standards, with the leadership of the Quality System team. This role involves leading quality assurance initiatives, managing quality documentation, and ensuring that all processes meet the required quality standards.

Job Description

Key Responsibilities:

Quality Management System (QMS) Implementation and Maintenance:

• Maintain quality management systems at the plant, based on ISO 13485 and related corporate standards
• Ensure compliance with EU MDR, FDA 21 CFR Part 820, and other relevant regulations
• Develop and maintain quality processes and documentation
• Act as the primary quality representative for regulatory audits and inspections
• Ensure accurate and timely reporting of quality metrics and initiatives

• Responsible for internal and external quality audits. Prepares and organize external audits. Ensure each key contributor is available and prepared
• Oversee process for corrective and preventive actions (CAPA) and ensure the timely and appropriate execution
• Ownership at change control process

• Train and coach associates on QMS processes and regulatory requirements
• Ensure that employees are compliant with quality standards through regular training sessions

• Work closely with cross-functional teams, including internal (Production, Training/CI team, Engineering) and external (WW Quality System, Regulatory Affairs)
• Collaborate with external providers and suppliers to ensure quality standards are me
• Report to management on quality issues, trends, and effectiveness

• BS/MS in Engineering or a relevant Life Science discipline

• 5+ years of experience in a similar position
• 10+ years of experience in manufacturing environment within automotive-, electrical- or medical device industry
• Experience in quality auditing (hosting and executing)

• Fluent in Hungarian and English
• Expertise in implementing and maintaining Quality Management Systems (QMS)
• Strong leadership skills to guide and motivate QS team and other cross-functional teams
• Excellent communication skills for effective collaboration and reporting
• Strong analytical skills to identify and resolve quality issues
• Proficiency in data analysis and quality metrics reporting
• Ability to work effectively in a team
• GMP and ISO 13485 knowledge is nice to have

• Ability to work in a fast-paced and dynamic environment
• Ability to manage multiple projects and prioritize tasks effectively