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Baxter Logo Baxter · Quality Control

Quality Engineer Associate III

United States, Round Lake Employment contract 96000.00 - 132000.00 USD / Year · Job Posted June 16, 2026
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Job Description

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.

Job Responsibility

  • 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

Requirements

  • 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

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • 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
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • educational assistance programs
  • 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
  • paid parental leave
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits
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