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Quality Manager

Req #: JR - 039822 Location Bajos de Haina, Provincia de San Cristóbal, Dominican Republic Job Category: Quality Control Date Posted: 09/12/2021

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Quality Manager

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.

SUMMARY:

Develop, coordinate and manage overall engineering resources and programs to assure full compliance with Corporate, ISO and FDA regulations.  Drive process improvement and monitor product performance through identification, and support to key related projects and data trending through Monthly Indicators and Quality Trends / Management Review Meetings.

Key player to manufacturing, validation and CAPA process, providing technical statistical support to assure process control.   

CAPA, NCR and Complaint subject matter expert (SME) to manage overall plant effort and programs of regulation and standards requirements to assure full compliance to implement them on site in a timely manner. Manages coordinates and execute listed duties and responsibilities. 

DUTIES AND RESPONSIBILITIES:

1.    Manage engineering resources to set workload priorities in areas of responsibilities as established by Management.   

2.    Assure Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP) principles are used, that all elements of the Complaints processes are clearly documented in each file and Corporate Complaints process objectives are met. 

3.    Analyzed Complaints, CAPA and NCR indicators and submit them to management for review in the corresponding quality boards. 


4.    Gather and analyzed information from other Quality Sub-Systems as inputs to the Complaints processes. 


5.    Identify Complaints stages and pending commitments in order to assure compliance with deadlines and if applicable, identify situations on time. 


6.    Initiates or recommends special studies and analyses of new products or processes to evaluate quality and reliability. 

7.    Evaluates and assures product’s quality through quality indicators and keeps product release performance within standards.  Provides Software Validation support as required.

8.    Responsible for the preparation and administration of the area Quality Engineering Group.

9.    Develop and evaluate Quality Sampling Plans techniques for further improvement. Supports the implementation process control activities.


10.    Develops and manages VIP objectives and monitors implementation results.

11.    Monitor and approves all manufacturing and quality Standard Operating Procedures and compliance.

12.    Controls Statistical concepts until its final implementation.

13.    Assist the Quality Operations superintendent in the evaluation and decision towards the acceptability or rejections of products.

14.    Lead the Quality Project hopper, and administrate projects follow up for the Quality Area. Coordinates and evaluates new projects with pertinent plant personnel.

15.    Participate and maintain full knowledge of the Operations / Management Review/ Quality Project Review. Assure quarterly Quality System Management reviews are in order to identify areas for opportunities, both for productivity and quality improvements, supporting our facility quality improvement process.

16.    Revises specifications and recommends changes.

17.    Approve Complaints related local specifications and procedures. Develop deep understanding of CAPA-Complaint specifications and Standard Operating Procedures (SOP’s) and convey to the plant. 


18.    Initiates or recommends special studies and analyses of new products or processes to evaluate quality and reliability. 


19.    Supports on FDA and Third-Party inspections.


20.    Any special project as assigned.


21.    Observes all company and regulatory EHS requirements.


22.    Identify hazards and evaluate risks and environmental aspects of areas and processes under    responsibility and implement appropriate control.


23.    Learn and practice basic ergonomic principles to reduce job-related discomfort and injuries.


24.    Perform other related duties complementary to the post as assigned.

25.    Identify and evaluate all risks and environmental aspects of the area of responsibility. Able to recognize new risks.

26.    Assure the compliance with the activities related to the Plant Calibration Program.

27.    Ensure that personnel under his/her supervision are trained and know the risks and environmental aspects of the area

EDUCATION AND/OR EXPERIENCE:


•    Bachelor’s Degree in science (B.S.) –, Pharmacy, Industrial Engineering or related field. Other bachelor’s degrees may be considered if it is commensurate with significant quality assurance experience in a Medical Devices or regulated industry. 


•    At least Eight (8) years of experience in Quality. 


•    American Society for Quality (ASQ) Certified Quality Engineer CQE) – or Green Belt certification, preferred.  


•    Experience in validation processes, manufacturing process of medical devices and implementation of projects.

LANGUAGE:

Fully bilingual, English & Spanish.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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.

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Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

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