Quality Associate Engineer III,

About the role

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

Pay

The estimated base salary for this position is $96,000 - $132,000 annually. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Benefits

• 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 including 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
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits