Senior Quality Engineer - Bioprocess & Compliance

RepliGen Corporation; California (MO); On-site; USD 110,000 - 150,000; Full time

Job summary

The Senior Quality Engineer at Repligen in Rancho Dominguez leads quality activities across manufacturing, engineering, and customer quality, ensuring compliance with ISO 9001, GMP, and FDA requirements; driving improvements to product quality and risk reduction.

You will guide investigations, CAPA, risk assessments, process validation, supplier quality, and audits; work with cross‑functional teams to maintain a robust QMS and support business growth.

Qualifications

• Bachelor's degree in Engineering or Life Science and 7+ years in quality/manufacturing engineering.
• Knowledge of ISO 9001 and FDA 21 CFR 820; strong problem-solving skills.
• Experience with CAPA, audits, quality planning, and data analysis.

Responsibilities

• Lead investigations, CAPA, risk assessments, and data analysis to drive improvements.
• Oversee process validation, change management, and supplier quality activities.
• Prepare for ISO/audits; support customer complaint investigations and QMS maintenance.
• Interface with Engineering, Manufacturing, Marketing, and customers; provide training as needed.
• Occasional travel may be required based on business needs.

Skills

Quality engineering

Investigations

CAPA

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Science

Tools

MasterControl

Minitab

Excel

Job description

The Senior Quality Engineer at Repligen in Rancho Dominguez leads quality activities across manufacturing, engineering, and customer quality, ensuring compliance with ISO 9001, GMP, and FDA requirements; driving improvements to product quality and risk reduction.

You will guide investigations, CAPA, risk assessments, process validation, supplier quality, and audits; work with cross‑functional teams to maintain a robust QMS and support business growth.