Abbott
Healthcare
QualityEngineerII
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Engineer II at Abbott. Skills: Quality engineering, Manufacturing support, Continuous improvement, Compliance. Provide quality engineering support for manufacturing operations. Support production activities to ensure compliance”
Industry & Context.
Investigation; Analysis; Risk assessment; Root cause analysis; Troubleshooting
10% travel, Continuous sitting, Continuous standing
What They're Looking For.
Must Have
Bachelor's degree in Engineering, Science, or related technical field with 3+ years of quality engineering, manufacturing engineering, or related experience, 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 Have
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
What You'll Do.
Provide quality engineering support for manufacturing operations
Support production activities to ensure compliance
Assess manufacturing issues
Recommend corrective actions
Lead investigations associated with complaints
Lead investigations associated with nonconforming material
Lead investigations associated with deviations
Lead investigations associated with quality events
Support CAPA activities
Implement corrective actions
Participate in risk assessments
Participate in quality impact evaluations
Identify opportunities to improve product quality
Identify opportunities to improve process performance
Identify opportunities to improve operational efficiency
Support decision-making using quality engineering tools
Support decision-making using statistical methods
Participate in cross-functional improvement initiatives
Support internal audits
Support external audits
Support regulatory inspections
Ensure compliance with FDA
Ensure compliance with ISO 13485
Ensure compliance with MDR
Ensure compliance with company quality system requirements
Maintain complete quality records
Maintain accurate quality records
Maintain complete quality documentation
Maintain accurate quality documentation
Work closely with Manufacturing
Work closely with Operations
Work closely with R&D
Work closely with Regulatory Affairs
Work closely with Supply Chain
Communicate quality risks
Communicate investigation outcomes
Communicate recommendations effectively
How You'll Work.
Team & Collaboration
Cross-functional teams; Manufacturing; Operations; Engineering; Quality teams; R&D; Regulatory Affairs; Supply Chain
Communication Scope
Communicate quality risks; Communicate investigation outcomes; Communicate recommendations
Full Job Description
Abbott 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. ## **JOB DESCRIPTION:** **Working at Abbott** 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](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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. **The Opportunity** 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, regul
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