Senior Quality Engineer: GMP/ISO & Continuous Improvement

Repligen Corp; California (MO); On-site; USD 110,000 - 150,000; Full time

Job summary

Repligen Corp in Rancho Dominguez, CA is seeking a Senior Quality Engineer to serve as a key quality representative across manufacturing, engineering, operations, supply chain and customer quality groups. You will drive quality improvements and ensure products meet quality standards and regulatory requirements.

The role provides technical leadership for investigations, CAPA, risk assessments, process validation, change control, supplier quality, and customer complaint investigations, while

Qualifications

• Bachelor’s degree in Engineering or Life Science and 7+ years of QA/Manufacturing Engineering experience.
• Working knowledge of ISO 9001 and FDA 21 CFR 820 quality regulations.
• Experience with CAPA, quality auditing, root cause analysis, and statistical data analysis.

Responsibilities

• Lead quality investigations, CAPA activities, and root cause analyses.
• Provide technical leadership on risk assessments, process validation and change management.
• Oversee supplier quality activities and customer complaint investigations.
• Support ISO/audit activities (internal, ISO, and customer audits).
• Collaborate cross-functionally to maintain a robust QMS and improve quality.

Skills

Quality engineering

CAPA investigations

FMEA

RCA

Statistical analysis

Quality systems

Documentation

Interpersonal communication

Education

Bachelor's degree in Engineering or Life Science

Tools

MasterControl

eQMS platforms

Job description

Repligen Corp in Rancho Dominguez, CA is seeking a Senior Quality Engineer to serve as a key quality representative across manufacturing, engineering, operations, supply chain and customer quality groups. You will drive quality improvements and ensure products meet quality standards and regulatory requirements.

The role provides technical leadership for investigations, CAPA, risk assessments, process validation, change control, supplier quality, and customer complaint investigations, while