Quality Engineer (m/f/d)

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.

• Each role in Quality matters. Baxter ships its products globally to serve patients. Whether you're developing a new process or overcoming a production challenge, you'll have the chance to bring your creativity.

  Your work will impact our global operation.

  WHAT YOU'LL BE DOING:

• Ensure processes and procedures for Global Services Operations in the Southern cluster align with regulatory requirements, Corporate Quality Manual, and ISO 9001 and ISO 13485 standards.
• Actively participate in the design, implementation, and maintenance of quality processes in Service/Rental Centers and field operations to assure compliance.
• Build positive relationships with collaborators from local, regional, and global teams, including Commercial, Operations, CQA, and SQA teams.
• Manage Global Services Quality Systems Local Process Ownership, including documentation, procedures, training, internal and external audits, CAPA, non-conformities, post-marketing surveillance activities, supplier qualification, validation processes, change control, and risk assessment.
• Support compliance in Global Services processes within the Southern cluster, including Device Release, Labelling, Storage areas, Calibration, Decontamination, Equipment Validation, and Repair.
• Monitor critical metrics for quality, trend data, and take necessary actions using TS systems.
• Serve as Local QMR for Global Services Southern Cluster.
• Support or lead local and/or European projects as required.

• WHAT YOU'LL BRING:

• Degree in Engineering, or equivalent experience, in a related field.
• Proven experience in quality assurance roles, preferably within the medical device or healthcare industry.
• In-depth knowledge of ISO 9001 and ISO 13485 standards.
• Outstanding attention to detail and a dedication to producing flawless work.
• Strong problem-solving skills and the ability to successfully implement solutions.
• Excellent communication and collaboration skills.
• Proficient in English and Italian.
• Ability to travel as required.
• Preferred: Master’s degree or equivalent experience in a relevant field, experience with global quality systems, and additional certifications in quality management.

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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