Quality Associate II

Company: BAXTER
Location: Medina
Posted on: April 6, 2026

Job Description:

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. 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. Physical demands: 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. Be able to stand, sit and walk throughout the work day Work environment: 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. 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. 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. 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. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter 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. Know Your Rights: Workplace Discrimination is Illegal 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 . Powered by SonicJobs (an advertiser on GenZJobs). By applying, you consent to share your data with SonicJobs and the employer. GenZJobs or SonicJobs does not store or use your application data beyond facilitating the application. See BAXTER Privacy Policy at https://jobs.baxter.com/privacy and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions

Keywords: BAXTER, Cheektowaga , Quality Associate II, Science, Research & Development , Medina, New York