Quality Coordinator - Customer Complaints

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. 

Position Summary

The primary purpose of this position is to ensure our products and packaging meet stringent quality standards through a variety of sampling, testing and analytical processes upon the return of customer samples and feedback. 

Essential Job Duties

• Coordinate Customer complaint samples and verify container, components and over-pouch meet quality standards, verify the accuracy & legibility of the print and check for indications of leakage.
• Transport product samples to and from work area, for analysis and review. Reviewing samples of produced materials and visually inspect for irregularities and verify dimensions are within specification.
• Perform seal integrity testing on samples of produced materials.
• Compose technical writing to summarize findings from complaint investigations for a variety of audiences such as the end user customer as well as regulators such as the FDA. Write and complete sample analysis review, manufacturing batch reviews, and investigations regarding customer samples for Contract Manufacturing (CMO).
• Ensure timely completion for customer requests of Certificate of Analysis (COA).
• Document and complete tasks within complaint records in TrackWise Complaint Management System (CMS).
• Write and submit changes to a Standard Operating Procedure (SOP) when a process used by the Complaints QA requires an update.
• May be designated as a Subject Matter Expert (SME) on an assigned SOP or process.
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).
• Promote and sustain a clean and safe work area using 6S principles including maintaining and securing provided tools.

Work Environment

• May include working in a Class I, Class II, Class III or Class IV Controlled Environment which may include the following dress/gowning requirements: safety glasses, ear plugs, hairnet, beard cover, isolation mask, gown, hood, boots or shoe covers and gloves.
• May include working in a biosafety hood to decontaminate samples before processing.
• Majority of work is performed at a desk in an office setting or in a laboratory for sample analysis.

Required Qualifications

• High school diploma (or equivalent). College Associates degree preferred
• 2+ years of experience in Quality in an FDA regulated industry required with a focus in GDP
• 2+ years of administrative experience required
• Computer proficiency in Microsoft Word, Excel, POMs and Outlook
• Organizational skills to manage multiple priorities in a timely manner
• Communication skills: strong written and verbal communications skills are a must

Physical Requirements

• Requires the ability to stand/walk continuously throughout the shift
• Ability to lift and carry up to 25 pounds
• Normal visual acuity and the ability to distinguish color are necessary
• Must be able to squat, reach above shoulder level, reach (at or below shoulder level), kneel, twist and bend at the neck, twist and bend at the waist and balance

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 $35,200 - $48,400 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. 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.