Engineer, Quality

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.

The Quality Engineer has the following main responsibilities to ensure compliance to ISO13485:

• Support process developments and process changes to ensure these are validated effectively in manufacturing,  Also gaining in depth knowledge of the processes and be a key role in pFMEAs and their start-up in manufacturing.
• Support change controls/design changes to ensure these are transferred in manufacturing with the right set-up to prevent manufacturing issues or complaints from the customers.  This is done through assessments, process validations, pFMEAs, design transfers and related tasks.
• Perform process validations as deemed necessary.
• Perform test method validations documentation and execution in the quality labs, and ensure these are done in a timely and compliant manner.
• Conduct Master Validation Plan periodic reviews and closure of any gaps identified as applicable.
• Ensure Data Integrity compliance and provide support in Computer Systems Validations.
• Ensure compliance to customer and regulatory requirements and Baxter Quality Management System standards.
• Work closely with the Engineering teams to ensure that process issues are resolved.
• Conduct internal audits and in-process assessments.
• Support TuV and corporate audits and any action items triggered during these audits.
• Ensure Environmental Health and Safety requirements procedures are adhered to in order to reach EHS targets and not jeopardize the health and safety of employees and environment.
• Ensure compliance to Good Documentation and Manufacturing Practices (GDPs and GMPs). Support Manager in other responsibilities, as needed.

Qualifications:

• Engineering degree or related field.

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.

Recruitment Fraud Notice

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