Quality Associate II

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.

Your Role at Baxter

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Associate II, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

• Own / Approve various Quality System Records.
• Responsible for conducting nonconformance root cause investigation, containment, correction, Field Action, corrective/preventive action, verification of effectiveness and closure activities.
• Identify, implement, and monitor process improvements to ensure continuous improvement to product and process quality.
• Mentor/coach Investigation Owners in developing investigation plan and results.
• Monitor Quality System related activities to ensure timeliness of completion.
• Verify respective functional activities for Quality System records are complete.
• Compile & present information to facility (Medina Plant) and external (i.e. Medina Design Center) CAPA Review Board. Maintain CRB information per established requirements, as needed.
• Develop and provide training as needed. Assist with Quality System Account Request Management.
• Generate weekly nonconformance reports, as needed.
• Participate in Audit readiness activities. Assist with / participate in Internal Audits, Corporate Audits, External Audits, as needed.
• Complete Global Observation Certification reviews and Quality Alert reviews, as needed.
• Provide support to the Change Control Management process by serving as a Quality Assessor.

• Bachelor's of Science in a science related field is required.
• 2+ years' experience in quality with a medical device/pharmaceutical company or similar regulated industry, preferred.
• Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, ISO 13485, preferred.
• Strong knowledge of risk management, root cause analysis, corrective and preventive action and document control.
• Demonstrated use of quality and root cause analysis tools, principles, and methodologies including statistical tools.
• Be able to author procedures in response to corrections or corrective actions.
• Have computer proficiency with experience in Microsoft Word, Excel, and Access or other database programs. Trackwise proficiency and experience is a plus.
• This role requires extensive personnel interaction, including all functions and all levels of the organization.
• Must have computer proficiency
• Ability to work effectively as part of a cross functional team
• Excellent organizational skills
• Excellent presentation skills
• Attention to detail
• Ability to multi-task and work well under pressure.
• 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
• True understanding of FDA Regulations, Application of Good Laboratory Practices, and Good Manufacturing Practices.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Be able to stand, sit and walk throughout the work day

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture.
• Wearing a static protective smock at all times while in the work area
• Working in close proximity to other employees.
• Working in an environment that is temperature and humidity controlled.

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.