Senior Quality Engineer - Process Excellence & Compliance

Abbott Laboratories; California (MO); Hybrid; USD 90,000 - 180,000; Full time

Job summary

Abbott Laboratories in California is seeking a Senior Quality Engineer to develop and maintain quality engineering methodologies across new product development and manufacturing. You will lead quality initiatives, apply Six Sigma and Lean methods, mentor teams, and ensure compliance with FDA, GMP, ISO 13485, and ISO 14971 while supporting cross-functional projects in a highly matrixed environment.

Strong problem solving, data analysis, and reporting skills are essential, with a focus on CTQ

Qualifications

• Minimum 5 years of engineering experience with quality tools/methodologies.
• Experience in manufacturing and new product development contexts.
• Strong familiarity with FDA, GMP, ISO 13485, and ISO 14971.

Responsibilities

• Identify and implement process control systems for product development and manufacturing.
• Lead, coach, and mentor staff; drive cross-functional quality projects.
• Apply systematic problem-solving to quality issues and CAPA.
• Lead risk analysis and participate in product verification and validation.
• Develop SOPs and DWIs; support QMS and EMS compliance.

Skills

Quality tools

Project management

Leadership

Communication

Data analysis

Report writing

Cross-functional collaboration

Medical device experience

Lean Six Sigma

FDA/GMP knowledge

Education

Bachelor's degree in Engineering or Technical Field

Job description

Abbott Laboratories in California is seeking a Senior Quality Engineer to develop and maintain quality engineering methodologies across new product development and manufacturing. You will lead quality initiatives, apply Six Sigma and Lean methods, mentor teams, and ensure compliance with FDA, GMP, ISO 13485, and ISO 14971 while supporting cross-functional projects in a highly matrixed environment.

Strong problem solving, data analysis, and reporting skills are essential, with a focus on CTQ