Quality Engineer - Process
Baxter International Inc.
Summary
Incumbent will be responsible for insuring compliance with the Quality System Regulation regarding Quality and Manufacturing Processes and methods. In order to perform effectively the incumbent must be knowledgeable of all processes, product specifications and quality functions. Provide the Aibonito facility with technical support to assure process control. Provide support and service to their respective areas. Responsible to ensure their responsibility areas are in compliance with internal and external regulations. Capable of supervising and or following instructions effectively and in timely manner. Provide the Aibonito facility with technical statistical support to assure process control. Participate in protocols, first of codes, Non-compliances and exceptions evaluation, changes of specs. SOP’s, special tests and /or projects.
Job description
What You'll Be Doing
- Responsible for compliance and providing Quality guidance for process/area responsibilities.
- Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.
- Leads and conducts root cause investigations for multi-group projects in the development of continuous improvement and corrective / preventative action philosophies and strategies.
- Support the Aibonito facility with technical knowledge, modification specifications and procedures, special tests and /or projects.
- Participate and maintain full knowledge of the Quality Operations.
- Participates in the process validation and protocols of equipment and/or subassemblies.
- Participates in the Software Validations and Protocols of equipment and/or database applications.
- Participate in the Quality Programs.
- Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.
- Able to review documentation in compliance with GMP and GDP.
- Support the design, development enhancement of product processes and technologies modifications.
- Evaluation of customer complaints.
- Conduct Non-conformance Investigations and be able to approve as quality representative.
- Develop and evaluate Quality Sampling Plans techniques for further improvement.
- Responsible for the Continuous Process Verification (CPV) program
- Any special project as assigned.
- Observes all company and regulatory EHS requirements.
- Prepare Quality Data Review on a monthly and quarterly basis.
- Participate in internal and external audits
- In charge of the analysis of Defect per Million (DPM) per defect/ product in a monthly basis
- Lead assigned programs (e.g. Sterilization, Parametric Release, etc.) from the quality standpoint to assure compliance.
- Review and approve related documentation.
- Evaluate sterilization alarms and provide final disposition to product based on procedures and specifications.
- Provide feedback and support to steam sterilization projects as subject matter expert.
- Must perform any work necessary to avoid the delay in the release of the product.
- Knowledge in Computer Programs (e.g. Microsoft Office, Outlook, Trackwise, TcU).
- Coordinate, participate and perform meetings with multidisciplinary teams as required.
- Prepare reports for management review and quality data indicators as required.
- Team worked oriented.
- Able to work under minimum supervision and to handle multiple tasks at the same time.
- Should be able to comply with the established projects goals and schedule milestones.
- Must be able to communicate effectively at any plant level.
What You'll Bring
- Bachelor's degree in engineering.
- At least one-year experience and statistical applications knowledge.
- Uses engineering and management practices/knowledge, statistical methods, computer systems and technical reporting.
- A self-starter capable of maintaining full understanding and up to the moment information of the Quality day-to-day activities.
- An individual with the ability of interacting with personnel from all levels, capable of supervising and or following instructions effectively and in timely manner.
- Must be willing to travel occasionally.
- Fully bilingual (English & Spanish).
Requirements
- Bachelor's degree in engineering.
- At least one-year experience and statistical applications knowledge.
- Uses engineering and management practices/knowledge, statistical methods, computer systems and technical reporting.
- A self-starter capable of maintaining full understanding and up to the moment information of the Quality day-to-day activities.
- An individual with the ability of interacting with personnel from all levels, capable of supervising and or following instructions effectively and in timely manner.
- Must be willing to travel occasionally.
- Fully bilingual (English & Spanish).
Benefits
- Medical, Dental & Vision
- Life Insurance
- Accident Insurance
- Short-term Disability
- Long-term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Family and Medical Leave
- 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.