Senior Quality Engineer - Medical Devices

Thornton Tomasetti; California; Hybrid; USD 90,000 - 180,000; Full time

Job summary

Abbott Laboratories is seeking a Quality Engineer to develop and maintain quality engineering methodologies across new product development, manufacturing, and services. You will lead process control systems, mentor staff, and collaborate across design, microbiology, and manufacturing functions to ensure regulatory compliance and product quality.

The role requires 5+ years of experience in quality engineering, expertise in Six Sigma/Lean, and strong data analysis and communication skills.

Qualifications

• Education: Bachelor's degree in engineering/technical field or equivalent experience.
• Experience: minimum 5 years in quality engineering or related roles.
• Supervisory experience preferred; use of quality tools/methodologies expected.
• Knowledge of FDA, GMP, ISO 13485, ISO 14971 required.
• Strong communication and interpersonal skills are essential.
• Demonstrated project management and leadership abilities across multiple teams.
• Proficient in statistics, data analysis, and report writing.
• Experience with Six Sigma and Lean Manufacturing methodologies.
• ASQ CQE or similar certification preferred.

Responsibilities

• Identify and implement effective process control systems for development, qualification, and manufacturing.
• Lead, coach, and mentor personnel across levels.
• Develop and execute streamlined systems to identify and resolve quality issues.
• Apply systematic problem-solving to prioritize and resolve quality issues.
• Design and conduct experiments for process optimization.
• Document experiment plans and results, including protocols and reports.
• Lead process control and monitoring of CTQ parameters and specs.
• Lead improvement methodologies (Six Sigma, Lean) across products and processes.
• Investigate, resolve, and prevent nonconformances.
• Collaborate with cross-functional teams on quality decisions and practices.
• Contribute to risk analysis and product verification/validation activities.
• Support Quality Management Systems (QMS) and Environmental Management Systems (EMS).
• Prepare SOPs and DWIs for business units and processes.
• Coordinate with Distribution Centers on quality issues and corrective actions.
• Support process development and new product introduction for externally manufactured items.

Skills

Quality tools/methodologies

Six Sigma

Lean Manufacturing

Project management

Leadership

Statistical analysis

FDA/GMP/ISO knowledge

Communication skills

Teamwork

Problem solving

Education

Bachelor's Degree in Engineering or Technical Field

Tools

Statistical analysis software

Job description

Abbott Laboratories is seeking a Quality Engineer to develop and maintain quality engineering methodologies across new product development, manufacturing, and services. You will lead process control systems, mentor staff, and collaborate across design, microbiology, and manufacturing functions to ensure regulatory compliance and product quality.

The role requires 5+ years of experience in quality engineering, expertise in Six Sigma/Lean, and strong data analysis and communication skills.