Supervisor Operaciones de Calidad - Turno C

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.

You role at Baxter:

This role is responsible for ensuring compliance with the Quality System Regulation regarding Quality and Manufacturing Processes and methods. In order to perform optimally the Quality Supervisor must be knowledgeable of all processes, product specifications and quality functions. Provide support and service to their respective areas. Responsible to ensure their responsibility areas are in compliance with internal and external regulations Provide the Haina facility with technical statistical support to assure process control. Participate in protocols, first of codes, Non-compliances and exceptions evaluation, changes of specs. SOP’s, special tests and /or projects.

#this is where your creativity addresses challenges!

Your Team:

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Every contributor at Baxter touch a portion of our global operation.

What you'll be doing:

We participate and maintain full knowledge of the Operations / Management Review,

We assist in the development/implementation of Quality Inspectors, be a facilitator of long-term Quality Programs.Responsible for quality inspector’s assignment to the lines.

We are part of the process validation and protocols of equipment and or new subassemblies, as well as participates in the Software Validations and/or database applications. Support POMs initiatives related with the introduction of codes in this system.

We are responsible for controlling overtime work for directs reports, quarantine cages and responsible for reworks execution and retentions administration.

We keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies, assure appropriate printing material handling Also evaluate failure modes associated with product and process changes.

Evaluation of customer complaints and implementation of Corrective and preventive Actions, active participation and support on Nonconformances (NCR, CAPA, etc.) and part of multidisciplinary team (as applicable), being owner of action items and investigations associated to internal or external audits.

Develop and evaluate Quality Sampling Plans techniques for further improvement, as well as Support the design, development improvement of new product processes and technologies, meeting with manufacturing, IT, Process/Product and Automation Engineering to help with the implementation/evaluation of new or improve process and for equipment.

Verify DHR documentation and assure that applicable specifications and local procedure are followed. Responsible for shipping disposition of final product or sub-assemblies.

Observes all company and regulatory EHS requirements, Identify hazards and evaluate risks and environmental aspects of areas and processes under responsibility building and implementing appropriate control, ensuring that personnel under their supervision are trained and know those aspects in the area.

Owner of medium & high complexity Quality improvement Projects and any special project as assigned.

What you'll bring

• BS Degree in Science, Engineering or related field.
• 3 years of proven experience in Medical Device Industry, preferably in Quality areas
• More than 1 year in previous supervisory experience
• One year of proven statistical application knowledge.
• English reading and writing.

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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