Sr compliance, QA Engineer

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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 Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

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

Sr compliance, QA Engineer

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This is where your 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.

Your role at Baxter

As Sr compliance QA Engineer, you will combine responsibilities in CAPA, Complaints, Risk, Internal Audit and Regulatory Affairs, ensuring conformity with regulatory mandates and driving the efficiency of quality systems at the Baxter Cartago plant.

Key features include:

Own the Complaints, CAPA, Risk Management, Hold and Corrective Actions systems, as well as their critical metrics and participation in local, regional and corporate forums. Implement the Internal Audit Program and follow up on corrective and preventive actions. Assess the regulatory alignment of processes and systems. Ensure they follow applicable directives and standards. Coordinate the system for change oversight, making sure changes stay in sync with regulatory requirements.

What you will be doing

Complaint, CAPA & Risk Management

Ensure evaluations of complaint samples, manufacturing investigations, and coordination with Product Surveillance within defined timeframes. Facilitate root cause analysis and ensure complete documentation in CAPA processes. Implement and maintain the risk system, assessing and controlling risks and leading residual risk. Ensure the accurate execution of the Hold process and the corrective field actions (FCA). Maintain effective communication with productive areas and lead actions to reduce complaints.

Internal Audit

Plan and implement internal audits, train the audit team, and keep your training program current. Coordinate preparation for external audits and ensure timely implementation of corrective or preventive actions. Maintain area indicators, communicate deviations, and ensure the plant is up to date with changes in FDA, ISO, or other regulations. Review Quality Alerts, 483s and Warning Letters, ensuring the detailed completion of required actions. Provide support in GMPs, CAPA and continuous improvement activities and health, safety and environmental programs.

Regulatory Affairs

Ensure ongoing regulatory compliance, leading and communicating changes to FDA, ISO, and other applicable requirements. Safeguard compliance during changes to systems or processes and handle the Change Control system. Assess regulatory risk through audit information, Quality Alerts, and Field Actions. Coordinate gap analysis against international standards and Baxter regulations

What will you bring?

Minimum of 4 years of experience in manufacturing processes, quality systems, regulatory compliance, and GMPs within Baxter or in companies producing healthcare devices. Validated knowledge of ISO 9001, ISO 13485, PMD Law, CMDR, MDSAP, CFR 21 and the Manufacturing Maturity Program (CMMI). Validated experience in auditing systems and certification as an Internal Auditor. Knowledge and experience in Sterility Assurance. University training in Engineering (Production, Industrial, Chemical, Systems, Electrical, Electronics, Electromechanics) or related career. Equivalent experience in production environments with Quality Systems in the medical device manufacturing industry.

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, 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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Address

Explore this location 600 Mts. Oeste De Entranda Ave. Las Americas Parq.
Cartago
Costa Rica 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 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.”

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.”

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.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Sr compliance, QA Engineer

Overview

Success Profile

Sr compliance, QA Engineer

Your role at Baxter

Key features include:

What you will be doing

Internal Audit

Regulatory Affairs

Address

Share

Hear from Our Employees

Meet Christelle, Senior Quality Manager in Malta

Meet Lorena, Senior QA Associate in London, UK

Meet Gary, Quality Research Manager in Singapore

Related Content

Join Our Talent Community