Quality Engineer

RXinsider LTD.; Houston (TX); On-site; USD 61,300 - 122,700; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Excellent retirement plan with high-em

Tuition reimbursement and education

Global company with strong benefits

Job summary

Abbott in Houston, TX is seeking a Quality Engineer to develop and maintain quality systems for manufacturing and product transfers. You will implement QA processes, CAPA and process controls while leading cross-functional teams to resolve quality issues.

The role emphasizes structured problem solving, validation planning, and risk management in a highly regulated medical device environment. Travel and onsite work are required.

Qualifications

• Bachelors Degree in Engineering or Technical Field.
• 2+ years engineering experience with quality tools and methodologies.
• Experience with medical devices and regulatory requirements is preferred.
• Strong communication and leadership skills.

Responsibilities

• Develop and maintain quality engineering methodologies for manufacturing and site transfers.
• Lead quality assurance processes, CAPA, and process controls.
• Investigate quality issues using structured problem-solving methodologies.
• Develop validation protocols and reports (IQ/OQ/PQ, TMV).
• Lead CTQ monitoring and risk management activities.

Skills

DMAIC

Root cause analysis

Six Sigma

Lean Manufacturing

CAPA

Quality tools

Cross-functional collaboration

Project management

Communication

Attention to detail

Education

Bachelor's Degree Engineering or Technical Field

Tools

FDA regulations

GMP

ISO 13485

ISO 14971

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.

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 :

• Career development with an international company where you can grow the career of which you dream.
• 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 high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

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

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, escalte, 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

• 2+ years Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

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 – $122,700.00. In specific locations, the pay range may vary from the range posted.