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. 

Job Responsibilities

• Consider Safety of themselves and others as first and foremost.
• Manage, oversee, track and drive accountability, of all active projects in Cell 2 Quality.
• Interact with other global Baxter facility representatives (IPSO customers) that North Cove (Cell 2) supplies product to when quality issues arise. Work with Cell 2 Manufacturing to resolve these quality issues between other global Baxter facilities and North Cove in a collaborative way.
• Own, coordinate or lead multiple projects consecutively while performing other required job duties. Work with corporate teams when needed.
• Manage/oversee the department monthly and quarterly trends. Make improvements to trending as needs and requirements change.
• Become a resident SME of plastics areas. Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed in relevant area(s).  When required, assist other Quality areas in the successful performance of these activities.
• Perform the duties of the Cell 2 Quality Manager when needed. Run the Cell 2 Quality department on a daily basis when the manager is not available. 
• Cover the daily tasks and exceptions as they happen on the floor and oversee QT’s when floor QA is out.
• Other duties, tasks or projects as assigned.

Knowledge, Skill and Abilities

• Strong communication and interpersonal skills and great attention to detail are necessary.
• Strong project management skills are necessary.

• Possess a working knowledge of FDA Regulations and Application of Good Manufacturing Practices (cGMP) and Good Documentation Practices.
• Must have knowledge of FDA quality systems regulations, preferably experience interacting with FDA or similar regulatory agencies.
• Must have good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC, Fishbone Diagram).
• Write, review, and revise Standard Operating Procedure (SOP) and process changes when necessary and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Must be able to interact with, and influence others at various levels in multiple departments.
• Must have the ability to manage people, encourage teamwork and drive decisions.

Education and Experience Requirements

• Bachelor's degree in science or engineering required. Advanced degree in the life sciences, physical sciences or engineering preferred.
• Minimum of 5 years of quality experience in pharma, medical device or related field preferred.

#IND-USOPS

#LI-LF

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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 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

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.