Supervisor, Quality Operations - Turno C

Baxter Healthcare; Facatativá; Sur place; COP 80 911 000 - 113 276 000; Plein temps

Résumé du poste

Baxter Healthcare in the Dominican Republic is seeking a Quality Supervisor to ensure compliance with Quality System Regulations and provide technical support to the Haina facilities to guarantee robust process control.

You will participate in protocols, NCRs and CAPA, investigations, and audits; drive quality improvements; and collaborate with Manufacturing, IT, Process/Product and Automation Engineering. Bilingual English/Spanish and night shift availability are required.

Qualifications

• BS degree in science, engineering or related discipline.
• 3 years of experience in medical device industry, ideally in quality.
• Over 1 year of supervisory experience and knowledge of statistics.
• Fully bilingual (English & Spanish).
• Willingness to work night shift 11:00pm–7:00am.

Responsabilités

• Participate and maintain full knowledge of Operations / Management Review.
• Participates in the process validation and protocols of equipment and/or new subassemblies.
• Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.
• Support the design, development enhancement of new product processes and technologies.
• 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).
• Owner of action items and investigations associated to internal or external audits.
• Develop and evaluate Quality Sampling Plans techniques for further improvement.
• Meets with manufacturing, IT, Process/Product and Automation Engineering to assist in 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.
• Responsible for reworks execution, retentions administration, quarantine cages and overtime work for directs reports.
• Evaluate failure modes associated with product and process changes.
• Owner of medium & high complexity Quality improvement Projects.

Connaissances

Supervisory experience

Statistical applications knowledge

Bilingual English & Spanish

Formation

BS Degree in science/engineering

Description du poste

This is whereyour work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

About Us: Baxter’s Mission:

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 90 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.

Your role at Baxter:

As a Quality Supervisor you will be responsible for ensuring compliance with the Quality System Regulations as they relate to quality and manufacturing processes and methods. You will provide technical support to the Haina facilities to ensure process control. This is where you will participate in protocols, code firsts, evaluation of non-conformances and exceptions, spec changes. SOP's, special tests and/or projects.

Your team:

We develop quality products with the patient in mind, so our efforts are patient focused as well. That means you can be proud of our work and the value we bring to people every day. As a large multinational organization, you will have the opportunity to expand your knowledge through collaboration with diverse people, exposure to different facets of our portfolio and a management team that supports you and encourages continuous development.

The quality team is defined by a high sense of integrity, transparency in decision making, proactivity & a strong focus on results.

What you’ll be doing:

• Participate and maintain full knowledge of the Operations / Management Review.
• Participates in the process validation and protocols of equipment and or new subassemblies.
• Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.
• Support the design, development enhancement of new product processes and technologies.
• 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).
• Owner of action items and investigations associated to internal or external audits.
• Develop and evaluate Quality Sampling Plans techniques for further improvement.
• Meets with manufacturing, IT, Process/Product and Automation Engineering to assist in 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.
• Responsible for reworks execution, retentions administration, quarantine cages and overtime work for directs reports.
• Evaluate failure modes associated with product and process changes.
• Owner of medium & high complexity Quality improvement Projects.

What you’ll bring:

• BS Degree in science, engineering or related discipline.
• 3 Years of experience in medical device industry, preferably in Quality areas.
• More than 1 year in previous supervisory experience and statistical applications knowledge.
• Fully bilingual (English & Spanish).
• Availability to work from 11:00pm -7:00am (Monday through Friday).

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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,

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Antigua Carretera Sanchez, Km 18 ½ PIISA Industrial Park|Haina, San Cristóbal|Dominican Republic