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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