Quality Assurance Technical Services Engineer (m/w/d)

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

Your role at Baxter

In this role you will ensure that processes and procedures for Technical Services Operations are in compliance with regulatory requirements in Germany, Austria and Switzerland. You will actively participate in the design, implementation and/or maintenance of the quality processes in the field operations.

This role is based in Unterschleißheim near Munich (hybrid option)

What you'll be doing

• Quality support to Field Service operation activities in Germany, Austria and Switzerland

• Local process ownership for the Technical Services Quality Systems: documentation, procedures, training, internal and external audit, CAPA and non-conformities, compliance to post marketing surveillance activities (product complaints, medical device vigilance, and Field Corrective Actions), supplier qualification, validation process (IQ, OQ, PQ protocols), change control process and risk assessment

• Support and ensure compliance with field operations processes: device release, labelling, storage areas, calibration, decontamination, equipment validations and repair

• Maintain a strong relationship with the local Technical Services team

• Local Auditor and Local Trainer

• Quality KPIs- trending and actions

• Support or lead local and/or European projects

What you'll bring

• Master’s degree in electrical/electronic engineering or equivalent degree in the technical/technology field

• Minimum 1-3 years of experience in quality management in a medical device or technical service organization – quality processes related to service activity OR experience in technical service/ manufacturing environment

• Quality System and Quality Assurance knowledge in operations

• knowledge of ISO 9001:2015 and ISO 13485:2016

• Expertise in medical device or electro-mechanical products

• Ability to manage different tasks in an international environment

• Effective interpersonal skills

• Excellent written and oral communication skills in English and German. A third language e.g. Spanish, French or Italian is a plus

• Ability & 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.

Have we sparked your interest?

If you like the sound of the above role, can thrive in a fast-paced working environment and are excited about working in a learning and growth culture, then we’d love to talk to you. Apply direct on our Online System.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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