Quality Assurance Manager
vor 3 Wochen
We are seeking a highly skilled Quality Manager to join our team at Sidekick Health Germany GmbH. As a Quality Manager, you will be responsible for ensuring the implementation, monitoring, and continuous improvement of our quality management system, ensuring that 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 to ensure compliance.
- Support in the preparation of documents for market authorisation of our Class I software medical devices, including compliance with standards.
- Coordinate corrective and preventive actions (CAPA) and be responsible for risk management and change control.
- 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.
Sidekick Health is a global pioneer in digital health and therapeutics, committed to transforming patient-centred care through innovative solutions. We offer a diverse range of digital health programmes covering various therapeutic areas, including oncology, cardiovascular diseases, metabolic disorders, and inflammatory diseases.
We are headquartered in Reykjavik and Hamburg and employ over 250 people worldwide. Our team is dynamic and diverse, and we value positive, direct, and open interaction with each other.
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