Manager, Compliance Quality Systems

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:

You as Manager, Compliance Quality Systems, will be responsible for the quality assurance function at the plant level, ensuring regulatory compliance, adaptability of manufacturing processes, and operational quality. The mission of the position is to guarantee product quality and customer happiness. This is achieved by implementing management systems, controlling risks, improving continuously, and encouraging employee growth. All actions align with the business’s strategic objectives. Supervises the work of the engineers and technical personnel in charge, with the aim of guaranteeing compliance with the established specifications and ensuring the development and performance of the related quality systems.

What you will be doing:

Quality System Management

Ensure the establishment, maintenance and improvement of a quality system that meets the

with regulatory, normative and corporate requirements that allow for improvement

manufacturing processes, responding to the needs observed in the

Market complaints and behavior of the product in process.

b. Approve local specifications and procedures as a Quality Representative of the

Areas under their responsibility.

c. Act as the Quality function’s liaison during internal and external audits and interactions with regulatory bodies.

2. Risk Management and Compliance

Implement strategies to identify, assess, and mitigate quality risks in processes,

Equipment and materials.

b. To control the accurate administration of the material and human resources required for

Compliance with processes.

3. Technical and Business Leadership

Provide authority support to both on-site and off-site customers to ensure compliance with plant goals and company standards ds.

b. Promote improvement, simplification, innovation and consistency to regulatory standards projects.

c. Represent the Director of Quality in their absence and in strategic committees.

4. People Management and Talent Development

Build and complete development and training plans for the members of the department passionate about Quality.

b. Ensure the continuous training and development of the teams responsible for Quality Engineering.

c. Promotes a culture of quality, safety and continuous improvement at all levels of the organization

What will you bring?

Academic background:

Quality, Industrial, Chemical, Biomedical or related Engineering.

Experience:

• 10+ years in Quality roles, with at least 5 in leadership positions.
• Validated experience in quality management systems in the medical, biotechnology or pharmaceutical industry.
• In-depth knowledge of international laws and standards (ISO 13485, FDA, GMP, MDSAP, among others).
• Technical skills:
• Process engineering, validations and quality controls.
• Risk analysis and problem-solving tools (FMEA, Six Sigma, CAPA).
• Audit and regulatory compliance management.

Proficiency in oral and written English.

• Leadership proficiencies:

2. Inspiring and focused leadership.

3. Effective communication and collaborator management.

• Ability to develop high-performing teams.

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

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.