Quality Associate II

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

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.

Your Team at Baxter

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.

What you'll be doing

• 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.

What you'll bring

• 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.