Compliance assistant Jobs in Saalfeld

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Baxter Medical Systems enables peak procedural performance and connectivity across all care environments. From Emergency Care, Surgical Care, to Intensive Care and Med-Surge Care our solutions delivers real-time insights and help care teams deliver great outcomes. In order for surgical teams and nursing staff to work efficiently, digital systems and automated devices are vital to helping streamline processes, increase user comfort and enhance patient safety. Baxter takes this development into account and sets new standards with its intelligent and networked solutions.

We are looking to hire a Quality Engineer (f / m / d) – Technical Service in fulltime for our site in Saalfeld / Thüringen.

Summary :

This role supports the field service activities and service centers in the DACH region with regard to quality management as well as active participation in the design, implementation and maintenance of quality processes.

Tasks :

Ensuring compliance with quality assurance processes in the front and back office as well as in the field operations and service centers

Ensuring that Global Services processes and procedures comply with regulatory requirements, the company's quality manual, and ISO 9001 and ISO 13485 requirements

Maintaining close relationships with the Global Services team, Quality Technical Service team in EMEA and other relevant stakeholders

Responsibility for documentation, training, internal as well as external 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 technical / technological field

Several years(ggf. Job starter) 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

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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.