Abbott
Healthcare
SeniorQualityEngineer
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Quality Engineer at Abbott. Skills: Quality strategy, Complex investigations, Continuous improvement. Serve as quality lead for manufacturing operations. Develop quality strategies aligned with business objectives”
Industry & Context.
Root cause analysis
10 % travel
What They're Looking For.
Must Have
Bachelor's degree in Engineering, Science, or related technical field with 5+ years of quality engineering, manufacturing engineering, or related experience, 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
Nice to Have
Medical 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, knowledge of FDA Quality System Regulation, ISO 13485, CAPA, complaints, risk management, and manufacturing quality systems
What You'll Do.
Serve as quality lead for manufacturing operations
Develop quality strategies aligned with business objectives
Identify systemic quality risks
Drive sustainable improvements
Lead complex investigations involving complaints
nonconforming material
Provide guidance and technical oversight for quality engineering
Drive application of risk-based decision making
Drive application of quality engineering principles
Mentor and develop Quality Engineers
Provide coaching and technical guidance
Lead quality engineering activities across cross-functional teams
Lead high-impact quality improvement initiatives
Utilize data analysis and quality metrics
Identify trends and drive actions
Champion operational excellence
Champion quality culture initiatives
Lead interactions supporting internal audits
Lead interactions supporting external audits
Lead interactions supporting regulatory inspections
Ensure compliance with applicable regulations
Ensure compliance with standards
Ensure compliance with company procedures
Assess quality system effectiveness
Recommend quality system improvements
Partner with Operations
Partner with Manufacturing Engineering
Partner with Regulatory Affairs
Partner with Supply Chain
Partner with leadership teams
Present quality performance to management
Present quality risks to management
Present quality recommendations to management
How You'll Work.
Team & Collaboration
Cross-functional teams; Operations leadership teams; Manufacturing Engineering teams; Regulatory Affairs teams; R&D teams; Supply Chain teams
Communication Scope
Present quality performance; Present quality risks; Present quality 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. **Senior Quality Engineer** **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 Senior Quality Engineer serves as the quality leader for assigned manufacturing operations and provides technical l
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