Summary

Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.

Job description

Responsibilities

Support the execution and maintenance of Quality Compliance processes and procedures in accordance with site requirements, SOPs, and cGMP.
Support the Corrective and Preventive Action (CAPA) process, including record initiation, documentation, tracking, follow-up, and timely progression of assigned actions.
Support Nonconformance Report (NCR) activities and other quality records, as assigned.
Monitor open quality records and assist with follow-up of actions approaching or exceeding established due dates.
Support the collection, tracking, trending, and presentation of quality metrics, including CAPA/NCR timeliness, Right First Time (RFT), overdue records, and other applicable compliance metrics.
Assist with the preparation of routine Quality Compliance reports, dashboards, and presentations.
Review quality records for completeness, accuracy, and adherence to applicable procedures.
Assist with investigations, root cause analysis, corrective actions, and effectiveness activities, as assigned.
Identify documentation or compliance gaps and escalate issues to Quality leadership as appropriate.
Support continuous improvement activities related to CAPA, NCR, documentation, and other Quality Compliance processes.
Assist with audit and inspection readiness activities, including organization and retrieval of supporting documentation and evidence.
Communicate quality and compliance activities, record status, and identified issues clearly and in a timely manner.
Collaborate with Manufacturing, Quality, Engineering, and other applicable functions to support completion of quality system activities.
Participate in Quality and Manufacturing improvement projects using appropriate problem-solving, Lean, and process improvement tools.
Maintain working knowledge of applicable plant systems, procedures, documentation, and Quality Compliance processes.
Manage and prioritize multiple assigned tasks and quality records to support established timelines.
Comply with applicable Environmental, Health, and Safety (EHS) requirements.
Maintain a clean, organized, and safe work environment in accordance with 6S principles.
Notify the appropriate supervisor or manager when safety, quality, mechanical, or compliance issues are identified.

Knowledge, Skills, and Abilities

Basic understanding of quality systems and cGMP requirements.
Ability to learn and apply CAPA, NCR, and other Quality System procedures.
Strong attention to detail and documentation accuracy.
Ability to review information, identify discrepancies, and escalate concerns appropriately.
Strong organizational and time-management skills.
Ability to manage multiple assignments and priorities.
Effective written and verbal communication skills.
Ability to work effectively both independently and as part of a cross-functional team.
Basic analytical and problem-solving skills.
Proficiency in standard computer applications used for documentation, data analysis, and reporting.
Ability to perform assigned responsibilities with appropriate supervision.
Ability to travel as needed to perform job responsibilities.
Ability to sit, stand, and/or walk for extended periods.
Ability to reach above shoulder level and bend or stoop as required.
Must meet applicable visual acuity requirements as defined in Baxter Cleveland Human Resources Procedure 1.04.

Required Education and Experience

Bachelor's degree in Life Sciences, Science, Engineering, Quality, or a related discipline, preferred.
Basic understanding of quality systems and regulated manufacturing practices preferred.
Experience in an FDA-regulated or cGMP manufacturing environment, preferred.
Experience with CAPA, NCR, investigations, quality records, or compliance activities preferred.
Lean Manufacturing and/or continuous improvement experience preferred.
Six Sigma training or certification is a plus.

Requirements

Bachelor's degree in Life Sciences, Science, Engineering, Quality, or a related discipline (preferred)
Basic understanding of quality systems and regulated manufacturing practices (preferred)
Experience in an FDA-regulated or cGMP manufacturing environment (preferred)
Experience with CAPA, NCR, investigations, quality records, or compliance activities (preferred)
Lean Manufacturing and/or continuous improvement experience (preferred)
Six Sigma training or certification (a plus)
Basic understanding of quality systems and cGMP requirements
Strong attention to detail and documentation accuracy
Strong organizational and time-management skills
Effective written and verbal communication skills
Basic analytical and problem-solving skills
Proficiency in standard computer applications for documentation, data analysis, and reporting
Ability to travel as needed
Must be authorized to work for any employer in the U.S.

Benefits

Medical & Dental Day One
Life & Accident Insurance
Short & Long-Term Disability
Employee Stock Purchase Plan
401(k) Matching
Flexible Spending Accounts
Educational Assistance
Paid Holidays
Paid Time Off
Paid Parental Leave
Commuting Benefits
Employee Discount Program
Employee Assistance Program
Childcare Benefits

Company overview

Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.