Head of Quality

Head of Quality

Location: Hybrid - 1 day per week on-site in Aachen, Germany
Salary: Competitive, based on experience + Equity

Are you driven by quality and regulatory excellence in medical technology? This innovative start-up is developing a groundbreaking medical device that could expand access to life-saving surgery for millions.

As Head of Quality, you will take ownership of quality management, ensuring compliance with global regulatory standards while working alongside a highly skilled and experienced team.

• Develop, implement, and oversee the Quality Management System (QMS).
• Ensure compliance with ISO 13485, MDR, and 21 CFR 820.
• Act as Quality Management Representative (QMR) and primary contact for regulatory bodies.
• Lead internal and external audits, managing regulatory submissions and approvals.
• Drive continuous improvement initiatives to enhance product and process quality.

• Extensive experience in quality management within the medical device industry.
• Strong knowledge of ISO 13485, ISO 14971, MDR, and FDA regulations.
• Proven track record in leading audits and regulatory compliance processes.
• Business fluency in English (German is a plus but not required).