Quality Engineer I
1 week ago
The Quality Engineer will play a critical role in ensuring the quality of our products and processes. This individual will be responsible for conducting complaint analysis, supporting product design changes, and gathering data to support investigation of non-conformances.
Key Responsibilities- Conduct complaint analysis and support product design changes
- Gather data to support investigation of non-conformances
- Support the manufacturing plant through implementation of process improvements
- Conduct process/financial analysis and implement/drive change
- Manage small projects, including cost, implementation, and validation
- Provide statistical assistance to Quality and Production
- Evaluate sampling plans for current quality levels and test methods
- Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
- Compose protocols, final reports, studies, experiments, and general information reports for use by management
- Lead/coordinate validation efforts of new equipment and changes to existing equipment
- Assist in evaluation of customer complaints, risk management, and technical summaries
- Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP's, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 820), Corporate Quality Manual (CQM), ISO , Canadian Medical Device Requirements (CMDR), MDD 93/42/EEC, and other applicable standards and regulations
- Bachelor of Science degree in Engineering required
- Strong technical writing and investigation skills required
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo, etc.)
Baxter is an equal opportunity employer. We evaluate 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.
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