Senior Quality Engineer — Cross-Functional Quality Leader

Repligen Corp; California; On-site; USD 120,000 - 150,000; Full time

Job summary

Repligen Corp is seeking a Senior Quality Engineer for our Rancho Dominguez, CA site. You will partner with Manufacturing, Engineering, Operations, Supply Chain, and R&D to ensure high-quality products and drive quality improvements across the lifecycle.

The role emphasizes data-driven decisions, investigations, and cross-functional collaboration, with responsibilities spanning ISO audits, CAPA, and process enhancements to mitigate risk and improve customer satisfaction.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 7+ years in Quality/Manufacturing Engineering in regulated environment.
• Experience with quality systems and regulatory requirements.
• Strong investigative and problem-solving methodologies (CAPA, root cause analysis).
• Excellent verbal and written communication across technical and non-technical audiences.

Responsibilities

• Lead investigations and root cause analysis for manufacturing and R&D quality events.
• Perform FMEA, RCA, Gauge R&R, statistical evaluation, and SPC activities.
• Monitor metrology, calibration, and quality procedures to support excellence.
• Prepare quality plans, procedures, and specifications for products and materials.
• Conduct testing, validations, equipment qualifications, and data analyses.

Skills

Quality systems

Root cause analysis

CAPA

Data analysis

Investigations

Process improvement

Interpersonal communication

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MasterControl

Flowcharting software

MS Office

Job description

Repligen Corp is seeking a Senior Quality Engineer for our Rancho Dominguez, CA site. You will partner with Manufacturing, Engineering, Operations, Supply Chain, and R&D to ensure high-quality products and drive quality improvements across the lifecycle.

The role emphasizes data-driven decisions, investigations, and cross-functional collaboration, with responsibilities spanning ISO audits, CAPA, and process enhancements to mitigate risk and improve customer satisfaction.