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Summary

Displays understanding of the Quality Management System concepts. Under general supervision, is responsible for implementing Baxter quality policies to improve product quality and ensure regulatory compliance; performs related duties as required that contribute to development and sustaining of products and processes. Applies a solid understanding of complaint handling process. Utilizes standard investigation tools to investigate non-conformances and provide resolutions. As Quality Approver works with cross-functional teams to support design and labeling change controls. Understands product development, Design Control, process validation, lifecycle principles, risk management, lab operations, and TMV (test method validation) process.

Essential Duties and Responsibilities

• Analyzes data from various sources (Non-Conformances, Field Corrective Actions, Medical Device Reports, and Complaints) to drive decisions
• Based on complaint trend analysis establishes corrective/preventive actions as required, and develops, implements, and monitors methods and procedures to continuously monitor and improve customer satisfaction
• Utilizes DMAIC tools to promote a disciplined non-conformance investigation approach and participates in corrective and preventive actions (CAPA) related activities, including CAPA ownership if appropriate
• Provides quality guidance and approval to product design and process change controls to ensure compliance to the required Product Development Process (PDP) deliverables, resulting in the development and sustaining of safe and effective medical devices
• Supports product verification testing to ensure product reliability and conformance to specifications
• With minimal guidance, schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger project
• Assists project teams and Baxter plants to identify compliance risks as part of product lifecycle management
• Supports Quality internal and external audits. Serves as an internal auditor if required.
• Educates and trains peers or subordinates on product body of knowledge and GMP principles
• Supervise Lab technicians in the inspection, evaluation, and analysis of end product, work in-process, and returned goods.

Qualifications

• Bachelor’s degree in engineering is required
• Master’s degree is preferred
• 5-8 years of experience in Quality Engineering
• Black Belt from ASQ Preferred
• Knowledge of ISO standards, US Code of Federal Regulations and EU regulations
• Strong oral and written communication skills needed
• Excellent interpersonal skills required
• Device regulation (design control) experience required
• Display understanding of Quality Management System and working knowledge of 21CFR820 (quality systems regulation/good manufacturing practices for medical devices), ISO 13485, ISO 14971 (risk management), and GMP
• Familiarity with Minitab or any equivalent statistical tool is required.
• Proficient in product and process change controls and risk management
• Experience with cross-functional teams, including technical/non-technical work
• Ability to organize and present technical information with minimal assistance
• Demonstrates leadership skills and ability to work independently
• Apply DMAIC and statistical techniques to address issues and investigations
• Recognized as a technical subject matter expert by peers and other personnel within the business unit.

Travel: 10 %

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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Pay Transparency Policy

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.