Job Summary

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

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

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

1.Relevant certifications in medical device regulations and quality management systems are preferred.

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.