Quality Systems Specialist

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.

Let's save and sustain lives together!

Your Role at Baxter

Leads and monitors compliance with the quality system, FDA regulations and ISO 13485; supervises the CAPA system of the organization and supervises the process of improvement and assurance for Quality Systems.

What you'll be doing

• Ensure compliance with QSR part 820, ISO-13485 and other applicable regulations.

• Implements and supports methodologies and systems that improve product quality and QS (Management Review, QSR Training, ISO13485 or other elements).

• Leads pre-audit plan preparation to collect pertinent information to support third party Audits.

• Plans, organizes, implements and follows up to ensure that the Internal Audit Program is implemented and effective.

• Performs routine internal audits of the quality system and reports audit results. Coordination of the CAPA Review Board, acting as responsible for the oversight of the organization's CAPA system, and ensuring that it is established and maintained.

• Ensures meeting metrics like NCR's, CAPA's, and Audits promptly, bringing up issues to prevent quality metric violations.

• Coordination and execution of the Management Review Assist Quality System Manager in the development, documentation, implementation, and maintenance of quality system procedures, instructions, and records Follow up to the Quality Plans, support in the integration of the elements into the Quality System and provide support to other sites at corporate level in the Quality System Elements.

What you'll bring

• Professional in engineering or related fields with 5 - 8 years of experience in manufacturing operation as quality system specialist in medical industries, education or training in quality control techniques including quality system auditing (internal & external), and statistical sampling methods.

• Experience in medical device regulations and standards, including FDA medical device regulations covered under Title 21 CFR Part 820 and knowledge in ISO 13485.

• Advance level of English.

Are you ready to join our mission? Join us now!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Excellent benefits and professional growth.

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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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