Senior Quality Engineer - Cross-Functional Quality Leader

Repligen Corporation; Compton (CA); On-site; USD 115,000 - 155,000; Full time

Job summary

Repligen Corporation in Rancho Dominguez, CA seeks a Senior Quality Engineer to partner with Manufacturing, Engineering, Operations, Supply Chain and R&D to deliver high-quality biologics products. You will lead investigations, CAPA, audits, and quality improvements across the product lifecycle, and support new product introductions from concept through implementation.

The role emphasizes data-driven decision making, cross-functional collaboration, and adherence to regulatory requirements.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 7+ years of Quality/Manufacturing Engineering in regulated environments.
• Experience with investigative methodologies, CAPA, auditing, and statistics.
• Strong communication across technical and non-technical audiences.

Responsibilities

• Lead investigations and root cause analysis for manufacturing and R&D quality processes.
• Perform FMEA, RCA, Gauge R&R, and statistical evaluation to resolve issues.
• Monitor calibration and metrology to meet quality objectives.
• Prepare quality plans, procedures, and product/raw material specs.
• Review manufacturing plans for quality requirements and risk.
• Prepare documentation for QC points and manage CAPA activities.
• Facilitate ISO, internal and customer audits.

Skills

Root cause analysis

CAPA

Quality systems

Statistical analysis

Investigations

Communication skills

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MasterControl

Job description

Repligen Corporation in Rancho Dominguez, CA seeks a Senior Quality Engineer to partner with Manufacturing, Engineering, Operations, Supply Chain and R&D to deliver high-quality biologics products. You will lead investigations, CAPA, audits, and quality improvements across the product lifecycle, and support new product introductions from concept through implementation.

The role emphasizes data-driven decision making, cross-functional collaboration, and adherence to regulatory requirements.