Senior Quality EngineerAbbott 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 115,000 colleagues serve people in more than 160 countries.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 Senior Quality Engineer serves as the quality leader for assigned manufacturing operations and provides technical leadership across quality engineering activities. This role drives quality strategy, mentors quality engineers, leads complex investigations and improvement initiatives, and serves as a key partner to Operations leadership in achieving quality, compliance, and business objectives.What You'll Work OnServe as the quality lead for assigned manufacturing operations.Develop and execute quality strategies aligned with business objectives.Identify systemic quality risks and drive sustainable improvements.Technical LeadershipLead complex investigations involving complaints, CAPAs, nonconforming material, deviations, and quality events.Provide guidance and technical oversight for quality engineering activities.Drive application of risk-based decision making and quality engineering principles.Team Leadership and MentorshipMentor and develop Quality Engineers.Provide coaching and technical guidance to support team growth.Lead quality engineering activities across cross-functional teams.Continuous ImprovementLead high-impact quality improvement initiatives.Utilize data analysis and quality metrics to identify trends and drive actions.Champion operational excellence and quality culture initiatives.Compliance and Regulatory SupportLead interactions supporting internal audits, external audits, and regulatory inspections.Ensure compliance with applicable regulations, standards, and company procedures.Assess quality system effectiveness and recommend improvements.Cross-Functional InfluencePartner with Operations, Manufacturing Engineering, Regulatory Affairs, R&D, Supply Chain, and leadership teams.Present quality performance, risks, and recommendations to management.Required QualificationsBachelor's degree in Engineering, Science, or related technical field with 5+ years of quality engineering, manufacturing engineering, or related experience; orMaster's degree in Engineering, Science, or related technical field with 3+ years of quality engineering, manufacturing engineering, or related experience.Experience leading complex quality initiatives in a regulated industry.Preferred QualificationsMedical device industry experience.ASQ Certified Quality Engineer (CQE) or equivalent ASQ certification.Demonstrated experience mentoring engineers and leading cross-functional teams.Experience supporting FDA inspections and external audits.Strong knowledge of FDA Quality System Regulation, ISO 13485, CAPA, complaints, risk management, and manufacturing quality systems.The base pay for this position is $78,000.00 – $156,000.00.
In specific locations, the pay range may vary from the range posted.