Senior Quality Engineer

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:

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 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 On

Strategic Quality Leadership

• Serve 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 Leadership

• Lead 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 Mentorship

• Mentor and develop Quality Engineers.
• Provide coaching and technical guidance to support team growth.
• Lead quality engineering activities across cross-functional teams.

Continuous Improvement

• Lead 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 Support

• Lead 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 Influence

• Partner with Operations, Manufacturing Engineering, Regulatory Affairs, R&D, Supply Chain, and leadership teams.
• Present quality performance, risks, 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.

Preferred Qualifications

• 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.
• Strong knowledge of FDA Quality System Regulation, ISO 13485, CAPA, complaints, risk management, and manufacturing quality systems.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

     

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.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

HF Heart Failure

        

LOCATION:

United States > Atlanta : 387 Technology Circle NW Suite 500

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf