Req: JR - 046024
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.
At Gambro Dialysatoren GmbH in Hechingen, we are specialized in the development and production of innovative dialysators and dialysis catheders within the Baxter Group. Every day, around 1,300 highly qualified employees are committed to improving the quality of life of patients with kidney disease or renal failure.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The Product Quality department ensures that the design of a product is in compliance with applicable Regulations, Standards and Procedures. Close collaboration with R&D organizations is mandatory to achieve this goal.
Coordinate Quality Assurance activities within new product development and sustaining engineering projects for Renal therapies Baxter disposables portfolio
Review documents with Quality & Regulatory relevance for DHF issuing and maintenance
Ensure the compliance of the product design with applicable Regulations, Standards and Procedures
Act as quality approver for design change controls and CAPAs related to the product families assigned
Point of contact with Regulatory Affairs regional and local for registration of devices
Support internal and external audits
QUALIFICATION AND EDUCATION
University graduate in Engineering, Biomedical or Life sciences (e.g. chemistry, biology) is preferable.
Minimum 2-3 years of experience in Quality, Regulatory or R&D departments of medical device/pharma structured industries
Knowledge of Quality System Regulations and mandatory Standards applicable to medical devices
Soft Skills required: critical thinking, problem solving, collaboration, flexibility, communication and negotiation skills
Fluent in English
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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