Manufacturing Quality & Compliance Engineer

Katalyst CRO; Los Angeles (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a skilled Quality Engineer to ensure product quality, regulatory compliance, and process adherence across manufacturing environments. You will monitor production activities, manage CAPA and non-conformances, and support audits with cross-functional teams.

The role requires hands-on experience with FDA 21 CFR Part 820, ISO 13485, GMP, and QMS documentation, plus strong problem-solving and collaborative skills to drive continuous improvement and risk management initiatives.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience in medical device manufacturing preferred.
• Strong understanding of regulatory and quality systems.
• Good communication and cross-functional collaboration skills.

Responsibilities

• Monitor manufacturing processes to ensure product quality and compliance with defined standards.
• Manage non-conformances (Client), deviations, and CAPA activities.
• Perform root cause analysis (RCA) and implement corrective and preventive actions.
• Support internal and external audits (FDA, ISO).
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
• Maintain and update Quality Management System (QMS) documentation including SOPs, DHF, DMR, and DHR.
• Collaborate with manufacturing, engineering, and supplier teams to resolve quality issues.
• Drive continuous improvement initiatives using Lean Six Sigma methodologies.
• Perform process monitoring and support validation activities (IQ/OQ/PQ as required).
• Ensure proper documentation and traceability of manufacturing and quality records.
• Manufacturing Quality.
• GMP.
• ISO 13485.
• FDA 21 CFR 820.
• CAPA.
• Client.
• Root Cause Analysis (RCA).
• Risk Management (FMEA).
• Statistical Process Control (SPC).
• Audit Compliance.
• Quality Management System (QMS).
• Continuous Improvement.

Skills

Regulatory compliance

CAPA management

Root Cause Analysis

Lean Six Sigma

Process monitoring

Documentation & traceability

Cross-functional collaboration

Audits support

Education

Bachelor's degree in engineering or related field

Experience in medical device manufacturing

Job description

Katalyst CRO is seeking a skilled Quality Engineer to ensure product quality, regulatory compliance, and process adherence across manufacturing environments. You will monitor production activities, manage CAPA and non-conformances, and support audits with cross-functional teams.

The role requires hands-on experience with FDA 21 CFR Part 820, ISO 13485, GMP, and QMS documentation, plus strong problem-solving and collaborative skills to drive continuous improvement and risk management initiatives.