As an Associate Quality Assurance Engineer, you’ll partner with Operations to help ensure manufacturing processes, materials, and products meet quality and regulatory requirements. You’ll support validation and qualification activities, investigate quality issues, review production documentation, and assess materials for commercial release while contributing to process improvement and operational excellence.
What You’ll Work On
Partner with Operations as a Quality representative to review production records, executed test methods, and material disposition decisions before commercial distribution.
Review process and test method validation, equipment and facility qualification documentation, and calibration records; identify and resolve deficiencies before commercial use.
Support nonconformance and deviation investigations, assess process risks, recommend mitigations, and help improve manufacturing and quality processes.
Review and approve standard operating procedures and manufacturing work instructions, and conduct production-area audits to maintain compliance with cGMP, ISO, ICH, and internal quality standards.
Collaborate with cross-functional teams to resolve day-to-day quality concerns, maintain accurate documentation, and support continuous improvement.
Required Qualifications
Bachelor’s degree in engineering, science (with a focus on biology and/or chemistry), or a related field; or an associate degree in a related field with an additional two years of experience.
2+ years of experience in a manufacturing operations environment.
1+ years of experience applying quality principles and practices.
Knowledge of and experience working within a 21 CFR Part 820, ISO 13485, ISO 9001, and/or cGMP-regulated environment.
Strong communication and collaboration skills with the ability to work effectively across Operations and Quality teams.
Ability to work onsite at least 90% of the time, travel between Madison locations, and travel up to 5% away from the work location, potentially including overnight or weekend travel.
Ability to meet applicable PPE requirements and perform role-related physical activities, including lifting up to 40 pounds, with or without reasonable accommodation.
Authorization to work in the United States without sponsorship.
Preferred Qualifications
2+ years of experience in biotechnology manufacturing, preferably in a GMP and/or ISO 13485 environment.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
- The base pay for this position is
- $22.45 – $44.85/hour
- In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Quality Assurance
DIVISION
ONCO Cancer Diagnostics
LOCATION
United States > Madison : 1 Exact Lane
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
No
MEDICAL SURVEILLANCE
No
SIGNIFICANT WORK ACTIVITIES
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
