Senior Quality Engineer - Process Improvement Lead

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

Job summary

Abbott is seeking a quality engineering leader to develop and maintain quality methodologies across new product development, manufacturing, and service support. You will drive process control systems, mentor staff, and lead CAPA activities to resolve quality issues.

Ideal candidates bring 5+ years in quality roles, knowledge of FDA/GMP/ISO standards, and experience implementing Six Sigma and Lean. Strong communication and project management are essential in a matrixed environment.

Qualifications

• Bachelor's degree in Engineering or technical field or equivalent.
• Minimum 5 years of relevant experience in quality engineering.
• Solid knowledge of FDA, GMP, ISO 13485 and ISO 14971.
• Demonstrated supervisory experience preferred.
• Strong communication and project management skills.
• ASQ CQE or other certifications preferred.

Responsibilities

• Identify and implement process control systems for development and manufacturing.
• Lead, coach and mentor non-exempt and entry level personnel.
• Develop and execute streamlined business systems to resolve quality issues.
• Apply problem-solving methodologies to prioritize and resolve issues.
• Design and conduct experiments for process optimization.
• Document experiment plans, results, protocols and reports.
• Lead process control and monitoring of CTQ parameters.
• Implement Six Sigma and Lean manufacturing methodologies.
• Lead investigations and CAPA for nonconformances.
• Participate in quality teams and represent the Quality function.
• Develop and maintain risk analyses; support product verification/validation.
• Collaborate with design engineering and microbiology on product development.
• Support QMS, EMS, and regulatory initiatives; perform related duties.
• Develop SOPs and DWIs for the business unit and processes.

Skills

Quality engineering

Six Sigma

Project management

Leadership

Statistical analysis

Education

Bachelor's Degree in Engineering or Technical Field

Job description

Abbott is seeking a quality engineering leader to develop and maintain quality methodologies across new product development, manufacturing, and service support. You will drive process control systems, mentor staff, and lead CAPA activities to resolve quality issues.

Ideal candidates bring 5+ years in quality roles, knowledge of FDA/GMP/ISO standards, and experience implementing Six Sigma and Lean. Strong communication and project management are essential in a matrixed environment.