Quality Associate Engineer III

About the role

At Baxter, we believe every person deserves a chance to live a healthy life. 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, playing a critical part in advancing product quality and supporting key regulatory and operational priorities.

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 problem solving on the manufacturing floor.
• Lead multiple process/product improvement projects, design of experiments, validations, development of new methodologies, and improving existing methodologies, including data generation, report development, and presentation.
• Manage activities to achieve defined quality goals in an efficient, accurate, and timely manner, ensuring 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, and Regulatory Requirements.
• Partner with other functions, facilities, divisions, and regions to ensure successful implementation and compliance to procedures and 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 and demonstrate leadership as a subject matter expert in your area.
• Assist in writing validations, audits, and assessments.

Requirements

• Bachelor’s degree in Science or Engineering required.
• 5 or more years of experience in IT, Engineering, Science, or a related field.
• Working knowledge of FDA Regulations, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
• Strong technical writing skills, including the ability to clearly document audit findings within audit reports.
• Strong technical, analytical, and problem-solving skills.
• Good interpersonal, communication, influencing, and negotiation skills.
• Ability to understand scientific strategies and invent new methods or avenues of investigation.
• Good project management skills.

Pay

The estimated base salary for this position is $96,000 - $132,000 annually. The range reflects an anticipated salary range based on market data and other factors, which are subject to change. Individual pay is based on location, skills, expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Benefits

• Medical and dental coverage starting on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident.
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP) with employee contributions and company matching.
• Flexible Spending Accounts (FSAs).
• Educational assistance programs.
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence, including paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.

Applicants must be authorized to work for any employer in the U.S. Baxter is unable to sponsor or take over sponsorship of an employment visa at this time.