Manufacturing Quality 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

Job Description

Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring production activities, managing quality systems, and driving resolution of non-conformances. The role involves CAPA management, root cause analysis, audit support, and implementation of continuous improvement initiatives while collaborating with cross-functional teams.

• 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).
• Statistical Process Control (SPC).
• Audit Compliance.
• Quality Management System (QMS).

Job Description

Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring production activities, managing quality systems, and driving resolution of non-conformances. The role involves CAPA management, root cause analysis, audit support, and implementation of continuous improvement initiatives while collaborating with cross-functional teams.

Roles & 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.

Education & Experience

• 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.