Quality Assurance Manager
vor 1 Monat
About the Role
We are seeking a highly skilled Quality Manager to join our team at Sidekick Health Germany. As a Quality Manager, you will be responsible for implementing, monitoring, and continuously improving our quality management system to ensure our products meet the highest standards and comply with all relevant laws, guidelines, and standards.
Key Responsibilities
- Develop and maintain our quality management system (QMS) to ensure compliance with ISO 13485 and IEC 62304 standards.
- Implement and maintain regulatory process instructions (SOPs) and communicate with authorities.
- Support in the preparation of documents for market authorization of our Class I software medical devices.
- Coordinate corrective and preventive actions (CAPA) and be responsible for risk management and change control.
Requirements
- Degree in quality management, engineering, medical technology, or a comparable qualification.
- Sound knowledge of ISO 13485, IEC 62304 standards, and regulatory requirements for medical devices.
- Experience in risk management, CAPA processes, and quality audits.
- Strong communication skills and experience in liaising with authorities and implementing regulatory requirements.
- Ability to train employees in quality topics and continuously improve the QM system.
- Fluent written and spoken German and English.
About Us
Sidekick Health Germany is a global pioneer in digital health and therapeutics, committed to transforming patient-centered care through innovative solutions. We offer a dynamic and diverse team environment, flat hierarchies, and flexible working hours. We are an Equal Opportunity Employer.
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