Manufacturing Quality Engineer

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 (NCR), 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

NCR

Root Cause Analysis (RCA)

Risk Management (FMEA)

Statistical Process Control (SPC)

Audit Compliance

Quality Management System (QMS)

Continuous Improvement

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.