Senior Quality Engineer
$78,000–$156,000 year
On-site · Atlanta, Georgia, United States
Job Summary
Senior Quality Engineer at Abbott in Atlanta, GA. Leads quality strategy and acts as quality leader for assigned manufacturing operations within the Heart Failure division. Responsibilities include driving quality initiatives, mentoring quality engineers, leading complex investigations (complaints, CAPAs, nonconforming material, deviations, quality events), applying risk-based decision making, ensuring compliance through internal/external audits and regulatory inspections, and partnering cross-functionally with Operations, Regulatory Affairs, R&D, and Supply Chain to improve quality system effectiveness and drive operational excellence. Requires a Bachelor’s (or Master’s) in a technical field with 3–5+ years (or 3+ years with Master’s) in quality/ manufacturing engineering, experience in a regulated industry, and ASQ CQE certification preferred. Familiarity with FDA QSR, ISO 13485, CAPA, risk management, and quality systems; prior leadership and mentoring experience; ability to communicate quality performance and recommendations to management.
Required Qualifications
- Bachelor’s degree in Engineering, Science, or related technical field with 5+ years of quality engineering, manufacturing engineering, or related experience; or Master’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.
- 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.
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.