Job Description Position: Quality Engineer IILocation: Atlanta, GA – 387 Technology Circle NW Suite 500Division: Heart FailureBase Pay: $61,300.00 – $122,700.00 (may vary by location)Responsibilities Provide quality engineering support for manufacturing operations, ensuring compliance with applicable procedures and regulatory requirements.Assess manufacturing issues and recommend corrective actions.Lead investigations of 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 using quality engineering tools and statistical methods.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.Collaborate with Manufacturing, Operations, R&D, Regulatory Affairs, Supply Chain, and other stakeholders; communicate quality risks, investigation outcomes, and recommendations.Required Qualifications Bachelor's degree in Engineering, Science, or related technical field with 3+ years of quality engineering, manufacturing engineering, or related experience; or a Master's degree with 1+ year of related experience.Experience in a regulated industry.Experience with CAPA, complaints, investigations, audits, and risk management.Knowledge of FDA Quality System Regulation and ISO 13485.Preferred Qualifications Medical device industry experience.ASQ Certified Quality Engineer (CQE) or other ASQ certification.Other Job Information Work shift: Standard.Travel: Yes, 10% of the time.Medical surveillance: No.Significant work activities: Continuous sitting and/or standing for prolonged periods (more than 2 consecutive hours in an 8‑hour day).Equal Opportunity Employer Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law. English: Espanol:
