Abbott

Healthcare

QualityEngineerII

$61–123k Atlanta, Georgia, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“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.

Healthcare
Problems you'll solve

Investigation; Analysis; Risk assessment; Root cause analysis; Troubleshooting

Eligibility Requirements

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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