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Summary
Displays standard quality engineering principles to resolve difficult problems, from conception to final design with team input. Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. A functional understanding of FDA, ISO and Baxter Quality systems is also required.
Qualifications
- With minimal guidance, guides a team through the planning and execution of a smaller project or defined piece of a larger project.
- Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
- Ability to prioritize multiple tasks and supervises/coordinates an engineer and/or technicians on assigned work.
- Ensures compliance with quality system and regulatory requirements (Change Control , CAPA, etc.) to assure product quality.
- Performs and interprets statistical trending analysis to identify trends and emerging issues.
- Performs Change Control and Design Control activities to ensure that all the intended assessments are performed and requirements are met.
- Utilizes investigational tools to performed Nonconformance and CAPA activities.
- Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
- Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
- Effectively operate in and may facilitate cross-functional teams with guidance.
- Must be able to provide solutions that reflect understanding business objectives and cost implications.
- Capable of problem solving and dealing with ambiguous situations.
- Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Education/Experience
- Bachelor's degree in science or engineering and 5 - 8 years related experience.
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.
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Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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