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.
Your Role
* 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.
Your Profile
* 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).
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