Quality Assurance Specialist

vor 3 Wochen

Saalfeld, Thüringen, Deutschland Baxter Vollzeit

Transforming Healthcare with Quality Excellence

Baxter is a leading medical technology company committed to saving and sustaining lives. We are seeking a highly skilled Quality Engineer - Technical Service to join our team in Saalfeld, Thüringen.

About the Role:

This position supports the field service activities and service centers in the DACH region with regard to quality management. The successful candidate will actively participate in the design, implementation, and maintenance 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.

Requirements:

  • 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's Commitment:

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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