Associate Quality Engineer: Drive Process Controls & CAPA

Abbott; Houston (TX); On-site; USD 50,700 - 101,300; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Excellent retirement savings plan with

Tuition reimbursement

FreeU education benefit

Recognized as a great place to work

Job summary

Abbott in Houston, TX is seeking an Associate Quality Engineer to develop and maintain quality engineering methods and provide support within manufacturing or systems/services. This on-site daily required role supports CTQ parameters and CAPA, with opportunities to lead process improvements.

You will collaborate with design engineering and microbiology, ensure compliance with FDA, GMP, ISO standards, and contribute to risk analysis and QMS initiatives.

Qualifications

• Bachelors Degree in Engineering or Technical Field; Masters preferred.
• Knowledge of FDA, GMP, ISO 13485, and ISO 14971 is required or preferred.
• Solid communication and interpersonal skills; project management and leadership experience.
• Advanced computer skills including statistical/data analysis and report writing.
• ASQ CQE or other certifications preferred.

Responsibilities

• Identify and implement effective process control systems to support development and manufacturing of products.
• Lead in the implementation of assurances, process controls, and CAPA systems.
• Assist in development and execution of streamlined business systems to identify and resolve quality issues.
• Apply statistical problem-solving methodologies to identify and resolve quality issues.
• Design and conduct experiments for process optimization and improvement.
• Document experiment plans and results, including protocol writing and reports.
• Lead process control and monitoring of CTQ parameters and specifications.
• Lead and implement Six Sigma and Lean Manufacturing methodologies.
• Lead investigations and preventive actions for product and process non-conformances.
• Participate in teams supporting quality disciplines and act as Core Team member.
• Lead risk analysis completion and maintenance.
• Collaborate with design engineering on product verification and validation.
• Work with microbiology to ensure environmental monitoring considerations.
• Support Quality Management Systems, Environmental Management Systems, and regulatory requirements.

Skills

Quality tools/methodologies

FDA/GMP/ISO knowledge

Communication skills

Project management

Statistical analysis

ASQ CQE (preferred)

Education

Bachelor's degree in Engineering or Technical field

Masters degree preferred

Tools

CAPA systems

Job description

Abbott in Houston, TX is seeking an Associate Quality Engineer to develop and maintain quality engineering methods and provide support within manufacturing or systems/services. This on-site daily required role supports CTQ parameters and CAPA, with opportunities to lead process improvements.

You will collaborate with design engineering and microbiology, ensure compliance with FDA, GMP, ISO standards, and contribute to risk analysis and QMS initiatives.