Quality Engineer

Katalyst CRO; Pleasanton (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer with 0-3 years of experience to support quality systems, validation, CAPA, and regulatory compliance in a regulated medical device and pharma environment. You will collaborate with cross-functional teams to ensure product quality and compliance.

The role involves audits support, documentation maintenance, and contributing to continuous quality improvements across engineering, manufacturing, and R&D.

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, or a related field.
• 0-3 years of experience in Medical Devices, Pharma, Biotech, or other regulated manufacturing environments.
• Basic knowledge of FDA 21 CFR 820, ISO 13485, CAPA, Validation, and Quality Management Systems.
• Strong analytical, documentation, and communication skills.
• Exposure to CSV, IQ/OQ/PQ, ISO 14971, GMP, or cleanroom environments.

Responsibilities

• Support equipment, process, and software validation (CSV, IQ/OQ/PQ).
• Assist with CAPA, non-conformance (Client/MRB), and root cause investigations.
• Maintain quality documentation and analyze quality metrics.
• Support internal/external audits and ensure compliance with FDA, ISO 13485, and GMP requirements.
• Collaborate with Engineering, Manufacturing, and R&D on quality initiatives.

Job description

Summary

We are looking for a Quality Engineer with 0-3 years of experience to support quality systems, validation, CAPA, and compliance activities in a regulated medical device/pharma environment. The role involves working closely with cross-functional teams to ensure product quality and regulatory compliance.

Roles & Responsibilities

• Support equipment, process, and software validation (CSV, IQ/OQ/PQ).
• Assist with CAPA, non-conformance (Client/MRB), and root cause investigations.
• Maintain quality documentation and analyze quality metrics.
• Support internal/external audits and ensure compliance with FDA, ISO 13485, and GMP requirements.
• Collaborate with Engineering, Manufacturing, and R&D on quality initiatives.

Requirements

• Bachelor's degree in Engineering, Biomedical Engineering, or a related field.
• 0-3 years of experience in Medical Devices, Pharma, Biotech, or other regulated manufacturing environments.
• Basic knowledge of FDA 21 CFR 820, ISO 13485, CAPA, Validation, and Quality Management Systems.
• Strong analytical, documentation, and communication skills.
• Exposure to CSV, IQ/OQ/PQ, ISO 14971, GMP, or cleanroom environments.