Cartago, Provincia de Cartago
2 days ago
Sr Manager, Quality Engineer

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 Sr Manager, Quality Engineer, will own the quality assurance function at the plant level. You will ensure regulatory compliance, adaptability in manufacturing, and operational excellence. The mission is to guarantee product quality and customer happiness. This will be done through management systems, risk control, continuous improvement, and talent development. All efforts 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:

1. Quality System Management

1. Ensure the establishment, maintenance and improvement of a quality system that aligns with regulatory, normative and corporate requirements that allows the continuous improvement of manufacturing processes, responding to the needs observed in market complaints and product behavior in process.

2. Approve local specifications and procedures as a Quality representative of the areas under their responsibility.

3. Represent the Quality function during audits and with regulatory bodies from within the organization as well as from outside.

2. Risk Management and Compliance

Implement strategies to identify, assess, and mitigate quality risks in processes, equipment, and materials. Control the accurate administration of the material and human resources required for the fulfillment of the processes. Technical and Business Leadership

1. Provide guide support to internal and external customers to ensure compliance with plant goals and company standards.

2. Promote improvement, simplification, innovation, and initiatives passionate about meeting regulatory requirements.

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

4. People Management and Employee Growth

Build and complete development and training plans for the members working in the Quality sector. Ensure the continuous training and development of the Engineering teams passionate about Quality. Promote 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 partner 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.

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