Sr Engineer, Quality Assurance

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

Essential Duties and Responsibilities

• Support batch release through root cause analysis, investigation and process optimization.
• Conduct nonconformance and CAPA investigations with use of problem-solving techniques and technical writing skills.
• Supports the manufacturing plant through implementation of process improvements.
• Lead small projects (both new and improvement) to include cost, implementation, and validation.
• Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods.
• Composes protocols, final reports, studies, experiments, and general information reports for use by management.
• 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 210-211,820), Corporate Quality Manual (CQM), ISO 13485:2016, and other applicable standards and regulations.
• Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.
• Responsible for:
  • Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
  • Identifying problems relating to the product, process and quality system.
  • Initiating and implementing solutions through designated channels.
  • Establishing controls on a process and establishment of the verification/monitoring of such.
  • Driving improvements into the production process, from conception to sustainable production methods.

Qualifications

• Strong technical writing and investigation skills required.
• Working knowledge of applicable standards and regulations: Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820) and ISO 13485:2016.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.
• Familiarity with MINITAB preferred.

Education and/or Experience

• Bachelor's Degree required in Engineering.
• 3-5 years' experience in Quality a pharmaceutical or medical device organization or a similar regulated industry. Other relevant experience outside of Quality but in a regulated industry may be considered.
• Experience in manufacturing, particularly with a focus on adhering to relevant medical device regulations (21CFR820, 1SO13485, CMDR, MOD), is highly desirable.

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.

EEO is the Law
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Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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