Quality Engineer II

Abbott • Atlanta, GA

9d • $61,300 - $122,700 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level