Senior Quality Engineer: Lead Process & QA Excellence

Abbott; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

HIP PPO medical

Tuition reimbursement

Great retirement plan

FreeU education benefit

Wellness program

Job summary

Abbott is seeking a Quality Engineer to develop and maintain quality engineering methodologies across NPD, manufacturing, and system/services support. You will lead process control, CTQ monitoring, and cross‑functional teams to ensure products meet internal and external requirements.

The role requires a Bachelor's in engineering, at least five years of experience, and knowledge of FDA, GMP, ISO 13485, ISO 14971.

Qualifications

• Bachelor's Degree in Engineering or Technical Field
• Minimum 5 years of experience; supervisory experience preferred
• Engineering experience with FDA, GMP, ISO 13485, ISO 14971
• Solid communication and interpersonal skills
• Strong project management and leadership abilities; cross‑functional teams
• Advanced computer skills including statistical data analysis and report writing
• Prior medical device experience; Six Sigma/Lean experience preferred
• ASQ CQE or other certifications preferred

Responsibilities

• Identify and implement effective process control systems for development, qualification, and manufacturing of products
• Lead, coach, and mentor staff
• Develop and execute streamlined business systems to resolve quality issues
• Apply systematic problem‑solving to identify and resolve quality issues
• Design and conduct experiments for process optimization/improvement
• Document experiment plans and results (protocols and reports)
• Lead process control and monitoring of CTQ parameters and specs
• Lead improvement methodologies (Six Sigma/Lean) and manage nonconformances investigations
• Participate in cross‑functional teams supporting quality decisions and practices
• Support risk analysis completion and maintenance
• Collaborate with design engineering on product verification/validation
• Work with microbiology on environmental monitoring and related requirements
• Support QMS/EMS and regulatory compliance initiatives
• Perform other related duties; develop SOPs and DWIs
• Coordinate with Distribution Centers on quality issues and nonconformance actions
• Support process development and new product introduction for externally manufactured products

Skills

Quality engineering

Process control

Six Sigma

Lean Manufacturing

Statistical analysis

Project management

Leadership

Communication

Education

Bachelor's degree in Engineering or technical field

Tools

ASQ CQE

Job description

Abbott is seeking a Quality Engineer to develop and maintain quality engineering methodologies across NPD, manufacturing, and system/services support. You will lead process control, CTQ monitoring, and cross‑functional teams to ensure products meet internal and external requirements.

The role requires a Bachelor's in engineering, at least five years of experience, and knowledge of FDA, GMP, ISO 13485, ISO 14971.