Quality Associate Engineer III,

Baxter International Inc.; Round Lake (IL); On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement plan

Employee stock purchase plan (ESPP)

Paid time off and holidays

Job summary

Baxter International Inc. is seeking a Quality Associate III (Quality Engineer) to drive quality engineering initiatives in a pharmaceutical manufacturing environment.

The role leads validation efforts and quality improvements, enhancing visual inspection programs for sterile products and ensuring compliance with quality standards. You will partner with cross-functional teams to implement process improvements, manage audits, and support regulatory priorities while contributing to product quality

Qualifications

• Strong technical writing skills. Must be able to clearly document audit findings within audit reports.
• Strong technical, analytical and problem solving skills.
• Good interpersonal, communication, influencing, negotiation skills.
• Understand scientific strategies and be able to invent new methods or new avenues of investigation.
• Good project management skills

Responsibilities

• Lead ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities.
• Drive root cause problem solving for non-conformances in area of responsibility, and champion problems solving on the manufacturing floor.
• Lead multiple process/product improvement projects, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
• Manage activities in achieving defined quality goals in an efficient, accurate and timely manner.
• Ensure business needs and timeliness requirements of the department are met or exceeded.
• Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Partners with other functions, facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations
• Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements.
• Demonstrate leadership ability and be recognized by all levels of the facility as a subject matter expert in their area.
• Assists and writes validations, audits and assessments.

Skills

Technical writing

Problem solving

Project management

Interpersonal skills

Communication

Education

Bachelor’s degree in Science or Engineering

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

The Quality Associate III (Quality Engineer) is a key individual contributor responsible for driving quality engineering initiatives and supporting regulatory compliance within a pharmaceutical manufacturing environment. This role leads validation efforts and quality improvement projects, with a strong focus on enhancing and modernizing visual inspection programs for sterile products. The position partners cross-functionally to implement process improvements and ensure compliance to quality standards. This role plays a critical part in advancing product quality and supporting key regulatory and operational priorities.

What You'll Be Doing

• Lead ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities.
• Drive root cause problem solving for non-conformances in area of responsibility, and champion problems solving on the manufacturing floor.
• Lead multiple process/product improvement projects, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
• Manage activities in achieving defined quality goals in an efficient, accurate and timely manner.
• Ensure business needs and timeliness requirements of the department are met or exceeded.
• Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Partners with other functions, facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations
• Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements.
• Demonstrate leadership ability and be recognized by all levels of the facility as a subject matter expert in their area.
• Assists and writes validations, audits and assessments.

What You’ll Bring

• Bachelor’s degree in Science or Engineering required
• 5 or more years experience in IT, Engineering, Science or related field..
• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Strong technical writing skills. Must be able to clearly document audit findings within audit reports.
• Strong technical, analytical and problem solving skills.
• Good interpersonal, communication, influencing, negotiation skills.
• 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

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 $96,000 - $132,000 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.

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)

• 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.
• 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.
• 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.
• commuting benefits, the employee discount program, the employee assistance program (EAP), and childcare benefits.

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.

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.