Quality Engineer II – Medical Devices

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

Benefits offered by this job

Free HIP PPO medical coverage

Great retirement savings plan with a高?

Tuition reimbursement and educationBEN

FreeU education benefit

Wellness program access

Job summary

Abbott in the United States > Sylmar: 15900 Valley View Court is seeking a senior Quality Engineer to develop and maintain quality methodologies across new product development and manufacturing. You will lead cross-functional teams and drive process improvements in a highly regulated environment.

The role emphasizes Six Sigma/Lean techniques, risk analysis, documentation, and collaboration with design and microbiology to ensure product quality from concept through release.

Qualifications

• Minimum 5 years of experience in quality/engineering roles.
• Demonstrated use of quality tools and methodologies.
• Knowledge of FDA, GMP, ISO 13485, ISO 14971.
• Strong communication and interpersonal skills.
• Led multi-departmental project teams and quality issue resolution.
• Advanced computer skills including statistical/data analysis and report writing.
• ASQ CQE or other certifications preferred.

Responsibilities

• Identify and implement process control systems for development and manufacturing.
• Lead, coach, and mentor personnel.
• Develop and execute streamlined business systems addressing quality issues.
• Apply systematic problem-solving methodologies to 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.
• Lead and implement product/process improvement methodologies (Six Sigma/Lean).
• Investigate, resolve and prevent nonconformances.
• Support quality disciplines and cross-functional teams in decisions and practices.
• Lead risk analysis activities and support product verification/validation.
• Collaborate with design engineering and microbiology to ensure environmental considerations.

Skills

Quality engineering

Six Sigma

Lean Manufacturing

Project management

Data analysis

Report writing

Communication skills

Cross-functional leadership

CQE certification (ASQ)

Education

Bachelor's Degree in Engineering or Technical Field

Tools

FDA GMP ISO knowledge

Statistical software

Job description

Abbott in the United States > Sylmar: 15900 Valley View Court is seeking a senior Quality Engineer to develop and maintain quality methodologies across new product development and manufacturing. You will lead cross-functional teams and drive process improvements in a highly regulated environment.

The role emphasizes Six Sigma/Lean techniques, risk analysis, documentation, and collaboration with design and microbiology to ensure product quality from concept through release.