Manufacture quality engineer

Job Summary:

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.

Key Responsibilities:

• 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.

Skill Requirements:

• 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

Other Requirements:

• 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.