Associate Quality Engineer
Abbott
Summary
This position supports our Madison, WI locations within the Cancer Diagnostics business. 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.
Job description
The Opportunity
This position supports our Madison, WI locations within the Cancer Diagnostics business. 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.
Requirements
- 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
- 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
Benefits
- Medical Coverage
- Retirement Savings Plan
- Tuition Reimbursement
- Student Debt Program
- Education Benefit
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.