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Specialist, Compliance (Temporary)

Req # JR - 174792 Location Bajos de Haina, Provincia de San Cristóbal, Dominican Republic Job Category Engineering Date posted 06/05/2025
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Overview

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

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

  • Problem Solver
  • Analytical Thinker
  • Data Driven
  • Solution Focused & Results Oriented
  • Collaborative
  • Innovative

Specialist, Compliance (Temporary)

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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.

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.

Together, we build a place where we are happy, successful, and encourage 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!

Maintain compliance with corporate, FDA, ISO 13485, MDSAP, and other regulations. Handle assessment duties: Conduct internal audits, coordinate resources for efficient preparation, implementation, and reporting of external audit results, and monitor the accuracy and sufficiency of quality systems, procedures, and practices. Head Quality Trends, Audit Review, and Management Review Meetings. Co-lead the ICARE Program implementation at the site.

Serve as a mentor for investigation owners in audit responses.

What you'll be doing:

  • Manage resources and coordinate activities of the Internal and External Audit process.
  • Supervise the preparation of the internal audit schedule every year.
  • Coordinate the audit/assessment process with a group of plant-certified auditors, collecting and analyzing objective evidence regarding issues and risks.
  • Report findings to management and assure internal audits are performed within the scheduled timeframe.
  • Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness.
  • Mentor and coordinate investigation owners in leading all aspects of investigations and their accurate documentation.
  • Follow up to ensure Audit Observation Reports are received and completed within the established timeframe.
  • Confirm corrective and preventive action efficiency and report extended corrective actions to management.
  • Maintain External/Internal Audit files and Auditors Qualification records updated and available.
  • Assist in the execution and completion of the Certification Document Review (CDR).
  • Coordinate/support regulatory requests with the accurate resource to ensure timely performance and submission.
  • Participate in the development and delivery of GDP training programs and conduct cGMP training for new employees, providing annual cGMP training to all employees.
  • Lead external inspections from ISO, FDA, Customers, MDSAP, MDR, and others, maintaining accurate communication and crafting an atmosphere of credibility and confidence.
  • Maintain the Internal/External Audit metrics and report to Management as per established guidelines and as needed.
  • Report plant metrics in the Global system monthly.
  • Lead training program on Regulatory Standards like 21 CFR 820, ISO 13485, MDSAP, MDR, and other relevant regulations.
  • Co-responsible for ICare Program implementation at Haina.

What you'll bring:

  • Bachelor’s degree in industrial engineering related career.
  • Five (5) years’ experience in Quality, including at least two (2) years of experience in Auditing Techniques, Regulations, and ISO 13485 and 9000 Standards.
  • Preferred candidate will hold American Society for Quality (ASQ) Certified Quality Auditor (CQA) certification or equivalent experience.
  • Knowledge in GDP’s, GMPs, 21 CFR Part 820 - Medical Device Quality System Regulation (QSR), ISO 9001, MDSAP, and ISO 13485 Standards.
  • Proficiency in Microsoft Office Software.
  • Knowledge in Specs/SOP’s creation.
  • Familiarity with OSHA, GMP, General FDA Regulations, Good Documentation Practices, CAPA, Internal Audit, and Training.
  • Bilingual (English and Spanish).

At Baxter Healthcare Corporation, we value diversity and are committed to being an equal opportunity employer. We do not discriminate based on race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. If you need accommodations during the application or interview process, or to perform essential job functions, please contact us.

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

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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Address

Explore this location Antigua Carretera Sanchez, Km 18 ½ PIISA Industrial Park
Haina, San Cristóbal
Dominican Republic Explore This Location

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 Anwesha – recently promoted to Manager, she leads a team of software engineers for our Medication Delivery business.

“I grew up in a small coastal town in India called Bhubaneswar, where we have our own traditions and culture. I think this has helped me grow personally and professionally. Working with a global team at Baxter, my background helps me to be open, appreciate and relate to people from all different places.”

Meet Sam – he has been with Baxter for over 15 years, working as an Engineering Technologist in Round Lake, IL, US.

“I have a wonderful team. They have been flexible and open to the differences in communication methods and work style necessary for me to excel. If I didn’t have that support, I wouldn’t be where I am now and I wouldn’t have been able to advance within the company. I’m proud to work at Baxter.”

Meet Erika – she has been an engineer in Round Lake, IL, US for over four years, promoted to Senior Principal Engineer in 2019.

“My involvement with National Society of Black Engineers outside of work has afforded me the opportunity to manage Baxter’s external partnership with the organization, exposing us to networking and talent that can help drive diversity and innovation, and providing opportunities for more community engagement and involvement, which I know a lot of my colleagues like.”

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