Quality Associate II– Field Action Team

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. 

This Quality Associate II position will lead cross-functional teams as a Field Action (FA) Owner to facilitate the execution and closure of multiple US/global Field Actions. This position will support additional field action process activities as detailed below.

What you will be doing:

• Responsible for managing Field Actions (FAs) as FA Owner through FA closure.
• Lead daily departmental activities for areas of direct responsibility
• Manage activities of self and Field Action (FA) team members in achieving defined Quality/FA goals in an efficient, accurate, and timely manner. Must be recognized as an expert in their area and demonstrate leadership ability.
• Participate in FA review boards and Monthly reviews, as needed, oversee approvals for FA related documents, and drive FAs to closure per approved plans
• Lead FA Strategy team meetings to draft customer letters and Global FA Plans with global cross-functional teams.
• Interface with internal customers on issues and questions related to the implementation of FAs
• Prepare and Verify FA monthly status reports
• Assist with data collection and report generation
• Perform periodic reviews for FA communications and work closely with other FA staff to ensure accurate documentation and data is captured, entered and stored appropriately
• Work closely with regional gatekeepers, business leads, and FA team members to implement and support FA plans, track FA completion and resolve issues to drive FA’s to closure
• Present FA Metrics to management on an as needed basis
• Participate in internal and external inspections and assist with implementing solutions to audit findings
• Be directly involved in, and where appropriate, lead improvement projects which may include improving current FA processes, data generation, report development and presentation, or improving other quality processes /systems to demonstrate lean competencies

What do you bring:

• BS in business/science or equivalent
• 3-5 years of experience in Quality with a medical device/Pharma company or other similarly regulated industry
• Knowledge and understanding of regulations and standards (e.g. ISO9001, ISO13485, FDA 21CFR Parts 7,11,803,806,810,820, 821).
• Working knowledge of Baxter products, procedures, and internal electronic systems preferred.
• Proficiency in Microsoft Office (e.g. Excel, Word, OneNotes, and PowerPoint)
• Excellent written/verbal communication, problem-solving skills, and attention to detail.
• Self-motivated with the ability to work independently and make decisions.
• Strong project management skills.
• Demonstrated interpersonal skills and ability to lead others in interactions with people at all levels.
• Ability to perform multiple tasks simultaneously and work cross-functionally in a highly matrixed environment.
• General organizational office skills
• Knowledge of Good Documentation Practices and Good Manufacturing Practices.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $76,000 - $104,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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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 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.

Recruitment Fraud Notice

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