Quality Engineer II

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 that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

This position works out of our Atlanta, GA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Quality Engineer II partners with Manufacturing, Operations, Engineering, and Quality teams to ensure products consistently meet quality, regulatory, and customer requirements. This role provides quality engineering support for manufacturing operations through investigation, analysis, risk assessment, continuous improvement, and quality system activities. The Quality Engineer II independently manages routine and complex quality activities while driving timely resolution of quality issues.

• Provide quality engineering support for manufacturing operations.
• Support production activities to ensure compliance with applicable procedures and regulatory requirements.
• Assess manufacturing issues and recommend corrective actions.

• Lead investigations associated with complaints, nonconforming material, deviations, and quality events.
• Support CAPA activities including root cause analysis, effectiveness verification, and implementation of corrective actions.
• Participate in risk assessments and quality impact evaluations.

• Identify opportunities to improve product quality, process performance, and operational efficiency.
• Utilize quality engineering tools and statistical methods to support decision-making.
• Participate in cross-functional improvement initiatives.

• Support internal and external audits and regulatory inspections.
• Ensure compliance with FDA, ISO 13485, MDR, and company quality system requirements.
• Maintain complete and accurate quality records and documentation.

• Work closely with Manufacturing, Operations, R&D, Regulatory Affairs, Supply Chain, and other stakeholders.
• Communicate quality risks, investigation outcomes, and recommendations effectively.

• Bachelor’s degree in Engineering, Science, or related technical field with 3+ years of quality engineering, manufacturing engineering, or related experience; or
• Master’s degree in Engineering, Science, or related technical field with 1+ years of quality engineering, manufacturing engineering, or related experience.
• Experience in a regulated industry.

• Medical device industry experience.
• ASQ Certified Quality Engineer (CQE) or other ASQ certification.
• Experience with CAPA, complaints, investigations, audits, and risk management.
• Knowledge of FDA Quality System Regulation and ISO 13485.

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