Associate Quality Engineer

Abbott; United States; On-site; USD 31,000 - 62,000; Full time

Job summary

Abbott in Madison, Wisconsin is seeking a Quality Assurance professional to partner with Operations, reviewing production records, test methods, and disposition decisions before distribution to ensure compliance with cGMP, ISO, ICH, and internal standards.

You will support nonconformance investigations, assess process risks, and help improve manufacturing quality processes, while reviewing SOPs and conducting audits.

Qualifications

• Bachelor's degree in engineering, science, or related field (or associate degree with 2+ years' experience).
• 2+ years of experience in manufacturing operations.
• 1+ years applying quality principles and practices.
• Experience in 21 CFR Part 820, ISO 13485, ISO 9001, or cGMP environments.
• Strong communication and collaboration across Operations and Quality teams.
• Willingness to be onsite at least 90% of the time and travel as needed.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Partner with Operations as a Quality representative to review production records, test methods, and disposition decisions.
• Review validation, qualification, calibration records; identify deficiencies.
• Support nonconformance investigations, assess process risks, and recommend mitigations.
• Review and approve SOPs and work instructions; conduct production-area audits.
• Collaborate with cross-functional teams to resolve quality concerns and drive continuous improvement.

Skills

Communication

Collaboration

Education

Bachelor's degree in engineering/science

Associate degree + 2 years experience

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit-an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company recognized as one of the best big companies to work for, as well as one of the best places to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position supports our Madison, WI locations within the Cancer Diagnostics business.

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.

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.