Senior Quality Engineer: Lead Quality & CI (CA Onsite)

Regulatory Jobs; California; On-site; USD 115,000 - 155,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision insurance

Retirement benefits

Flexible spending accounts

Job summary

Regulatory Jobs in Rancho Dominguez, CA, is seeking a Senior Quality Engineer to partner across Manufacturing, Engineering, Operations, Supply Chain, and R&D to deliver high-quality products. Lead investigations, CAPA programs, and supplier quality initiatives from concept through implementation.

The role emphasizes data-driven decisions, strong problem solving, and a culture of quality, compliance, and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 7+ years of Quality Engineering and/or Manufacturing Engineering experience in a regulated environment.
• Working knowledge of quality systems and regulatory requirements.
• Experience with investigative/problem-solving methods, RCA, CAPA, quality planning, auditing, and statistical data analysis.
• Strong technical aptitude to evaluate quality requirements and interpret technical information.
• Experience with scientific investigations, validation activities, and process improvement initiatives.
• Excellent communication across technical and non-technical audiences.
• Proficiency with Microsoft Office and data tools; familiarity with eQMS like MasterControl is preferred.
• Experience in regulated industries (biologics/pharma) is preferred.
• CQE, CQA, Lead Auditor or related certifications are a plus.
• Ability to work in office and manufacturing/lab environments.

Responsibilities

• Lead investigations and root cause analysis for manufacturing and R&D projects; drive quality improvements.
• Perform FMEA, RCA, Gauge R&R, statistics, and process control activities to resolve issues.
• Monitor metrology/calibration to support operational excellence.
• Prepare quality plans, procedures, and specifications for consistent product quality.
• Conduct testing, validation, equipment qualifications, and data analysis; propose improvements.
• Ensure quality requirements are in manufacturing plans and identify risks early.
• Prepare documentation for critical QC points in manufacturing processes.
• Analyze data related to quality issues, initiate CAPA, monitor corrective actions.
• Investigate and report customer complaints to ensure timely resolution.
• Participate in ISO, internal and customer audits; promote continuous improvement.
• Prepare and review Quality Technical Agreements and supplier evaluations.
• Support process/product improvements, design reviews, and nonconformance investigations.
• Deliver ISO, GDP, and technical training to promote quality awareness.
• Build relationships across the organization to support quality and business objectives.
• Serve as quality liaison with Engineering, Manufacturing, Marketing and customers.
• May serve as Lab Safety Coordinator with Hazard Communication Program.
• Leverage AI-enabled/digital tools to improve efficiency and decision-making.

Skills

Quality engineering

Root cause analysis

CAPA

Auditing

Data analysis

Communication

MS Office

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MasterControl

Excel

Job description

Regulatory Jobs in Rancho Dominguez, CA, is seeking a Senior Quality Engineer to partner across Manufacturing, Engineering, Operations, Supply Chain, and R&D to deliver high-quality products. Lead investigations, CAPA programs, and supplier quality initiatives from concept through implementation.

The role emphasizes data-driven decisions, strong problem solving, and a culture of quality, compliance, and continuous improvement.