At Baxter, we are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond, driven by a mission to Save and Sustain Lives
Job Summary
At Baxter, we are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond, driven by a mission to Save and Sustain Lives.
As Sr Compliance QA Engineer, you will own Complaints, CAPA, Risk Management, and Internal Audit systems, ensuring conformity with regulatory mandates at the Baxter Cartago plant.
Your role involves ensuring ongoing regulatory compliance, safeguarding compliance during changes, and assessing regulatory risk through audit information and Quality Alerts.
Matching Summary
At Baxter, we are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond, driven by a mission to Save and Sustain Lives.
Skills & Requirements
Must-have
CAPA management
Complaint handling systems
Risk management implementation
Internal audit program execution
Regulatory compliance assessment
Change control system management
Nice-to-have
Driving efficiency of quality systems
Making a meaningful impact
Purpose and pride in work
Courage, trust, and collaboration culture
Key Requirements
Minimum of 4 years experience
Knowledge of ISO 9001, ISO 13485, PMD Law, CMDR, MDSAP, CFR 21
Experience auditing systems
Certification as an Internal Auditor
University training in Engineering or related career
Equivalent experience in medical device manufacturing