Quality Assurance Specialist
Vor 5 Tagen
We are seeking a highly skilled Quality Engineer to join our Technical Service team in Saalfeld, Thüringen. As a Quality Engineer, you will play a critical role in ensuring the quality of our medical devices and services, while also contributing to the development and implementation of quality processes.
Key Responsibilities- Ensure compliance with quality assurance processes in the front and back office, as well as in the field operations and service centers.
- Ensure that Global Services processes and procedures comply with regulatory requirements, the company's quality manual, and ISO 9001 and ISO 13485 requirements.
- Maintain close relationships with the Global Services team, Quality Technical Service team in EMEA, and other relevant stakeholders.
- Responsibility for documentation, training, internal audits, CAPA, and non-conformances, compliance with post-marketing surveillance activities, supplier qualification, validation processes, change control processes, and risk assessments within own area of responsibility.
- Support and ensure compliance with field and service center operations related to equipment release, labeling, storage areas, calibration, decontamination, equipment validation, repair, PM, and spare parts management.
- Monitor and establish quality KPIs and initiate actions.
- Support and lead local, European, and global projects and initiatives.
- Completed master's degree in biomedical, electrical/electronic engineering, or equivalent degree in a technical/technological field.
- Several years of experience in quality management in a medical device company or experience in technical service/manufacturing/R&D environment.
- Knowledge of quality systems and quality assurance in operations, as well as technical service processes.
- Knowledge of ISO 9001 and ISO 13485 standards.
- Ability to handle various tasks in an international environment.
- Ability to understand and troubleshoot technical systems.
- Affinity to IT systems and good office skills, especially in the use of MS-Excel.
- Fluent in German and English, both written and spoken.
- Willingness to travel.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy, which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
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