Associate Quality Engineer

Abbott; Madison (WI); Sur place; USD 31 000 - 62 000; Plein temps

Avantages offerts par ce poste

Health coverage

Retirement plan

Tuition reimbursement

Education benefit

Diversity & inclusion

Résumé du poste

Abbott in Madison, Wisconsin, is seeking an Associate Quality Assurance Engineer to partner with Operations to ensure manufacturing processes, materials and products meet quality and regulatory standards.

You will support validation and qualification activities, investigate quality issues, review production documentation, and assess materials for release while contributing to process improvement and operational excellence.

Qualifications

• Bachelor’s degree or higher in engineering or science with biology/chemistry focus.
• 2+ years in a manufacturing environment.
• Knowledge of quality principles and regulatory requirements (21 CFR Part 820, ISO 13485, ISO 9001, cGMP).

Responsabilités

• Review production records and test methods to ensure compliance before release.
• Validate processes and equipment qualifications; assess calibration records and deficiencies.
• Investigate nonconformances, deviations, and process risks; propose mitigations.
• Review SOPs and work instructions; perform production-area audits for regulatory compliance.
• Collaborate with Operations and Quality teams to resolve issues and drive continuous improvement.

Connaissances

Quality assurance

Cross-functional collaboration

Regulatory compliance

Documentation and record-keeping

On-site work readiness

Formation

Bachelor’s degree in engineering/science

Associate degree with 2+ years experience

Outils

GMP/ISO knowledge

ISO 13485 familiarity

Description du poste

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.

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.

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 per hour. In specific locations, the pay range may vary from the range posted.