United States - Texas - Houston, United States of America
Onsite
Job Title
Quality Engineer
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
The Opportunity
This position works out of our Houston, TX location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.
THIS IS AN ONSITE DAILY REQUIRED POSITION.
What You’ll Work On
This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing and during product manufacturing site transfer activities.
MAIN RESPONSIBILITIES
• Identify and implement effective process control systems to support the qualification and on-going manufacturing of products in compliance with FDA 21 CFR Part 820/ISO 13485 requirements
• Lead implementation of quality assurance processes, process controls, and CAPA systems in alignment with regulatory and internal requirements
• Assist in the development and execution of business systems that effectively identify, escalate, and resolve quality issues within a regulated framework
• Apply structured problem-solving methodologies (e.g., DMAIC, root cause analysis) to investigate and resolve quality issues
• Design and conduct experiments to support process validation, optimization, and continuous improvement
• Develop and approve validation documentation including protocols and reports (IQ/OQ/PQ, TMV where applicable)
• Lead process control and monitoring of Critical-to-Quality (CTQ) attributes and specifications
• Lead and implement continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies
• Lead nonconformance investigations, including NCR, CAPA, and complaint-related analysis, ensuring timely closure and effectiveness verification
• Participate as a core team member representing Quality in cross-functional product transfer and sustaining teams
• Lead and maintain risk management activities in accordance with ISO 14971, including hazard analysis, risk assessment, and risk control verification
• Work with Microbiology and Manufacturing to ensure compliance with environmental monitoring, contamination control, and sterilization requirements where applicable
Required Travel: 10-15%. For the first 6-12 months travel could be up to 50% including travel outside of the United States.
Required Education
Bachelors Degree Engineering or Technical Field.
Required Experience
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 and @AbbottGlobal.
The base pay for this position is
$61,300.00 – $122,700.00In specific locations, the pay range may vary from the range posted.
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