QMS Manager (Medical)

at  Top Remote Talent

An international company - a developer of diagnostic systems in medicine, is looking for an experienced Quality Management System Manager for long term cooperation.
The core of the product is a single platform for storing, processing, and viewing medical images in accordance with modern standards of radiation diagnostics.
The company is implementing Innovative solution providing modern radiology workflows such as advanced rendering technologies allow you to provide a visualization what was not possible before!
Company`s goal is to provide customers with a modern technological solution that matches their current tasks, equipment, and IT infrastructure.

REQUIREMENTS:

• Bachelor’s degree in Quality Management, Engineering, Biomedical Engineering, or a related field.
• Experience in quality management within the medical or pharmaceutical industry.
• Knowledge of ISO 13485, ISO 9001, MDR, and other international quality standards.
• Experience in conducting audits and managing documentation. Strong analytical and organizational skills.
• Ability to work in a team and effectively interact with various departments.
• Proficiency in English, sufficient for reading and drafting documentation.
• Ability to visit the office (Dusseldorf located)

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with international standards and requirements such as ISO 13485, ISO 9001.
• Ensure that all processes and procedures comply with regulatory requirements and standards, including the Medical Device Regulation (MDR) in the European Union.
• Conduct internal and external audits to assess the effectiveness of the QMS and ensure regulatory compliance.
• Prepare and manage quality documentation, including the creation, revision, and control of document currency.
• Train and support employees on quality management and regulatory requirements.
• Analyze and improve QMS processes to enhance efficiency and product quality.
• Collaborate with various departments to integrate QMS requirements into business processes.