Around the world, our employees are united by our mission to save and sustain lives. Together, we create a culture that encourages colleagues to pursue rewarding careers -- where everyone has the opportunity to do meaningful work as a part of a team they respect, in an environment that values each person’s contributions. We’re happy you’re interested in continuing your career journey with Baxter.

Summary:

The Quality Associate III will manage the coordination of the activities relating to the execution of the CAPA Quality System. He/She will handle multiple projects and 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. 

Essential Duties and Responsibilities:

• Lead ongoing daily CAPA Quality System activities for areas of direct responsibility and when required assist other Quality areas in the successful performance of these activities
• Manage activities of self in achieving defined quality goals in an efficient, accurate and timely manner
• Ensure business needs and timeliness requirements of the CAPA Quality System are met or exceeded globally
• Recognized by various levels of sites as a CAPA subject matter expert and be able to demonstrate leadership ability
• Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Understands and assures conformance to regulations in a section or department. Interfaces with regulators during regulatory inspections
• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
• Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility
• Provide guidance and coaching for the areas of responsibility as defined in items # 1 through #8 for less experienced individuals within the organization.
• Must have the ability to perform the responsibilities of the Quality Manager on an as needed basis

Qualifications:

• Understand scientific strategies and be able to invent new methods or new avenues of investigation
• Good interpersonal/communication/influencing/negation skills
• Good project management skills
• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices

 Education and Experience

• Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering is ideal
• CAPA Quality System training, Root Cause Analysis training, with 2-3 years of experience in owning and executing CAPA Quality System records, interpreting regulations and quality systems
• Minimum of 5-8 years of experience in Quality, or related field in the medical products industry

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 
EEO is the law - Poster Supplement

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.