Quality Engineer: Medical Devices, Process Excellence & CAPA

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 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.