Quality Executive

Job Title: Quality Engineering Executive

Location

Chhatrapati Sambhajinagar

Role Purpose

Responsible for ensuring product quality, regulatory compliance, validation activities, and implementation of quality systems for manufacturing operations in a regulated environment.

Key Responsibilities

• Ensure compliance with applicable quality standards, GMP, and regulatory requirements.
• Support validation activities for product, process, equipment, and utilities.
• Handle CAPA, non-conformity investigation, and root cause analysis.
• Support new product/process implementation and continuous improvement projects.
• Develop and maintain control plans, inspection plans, and quality documentation.
• Participate in internal/external audits and ensure closure of audit observations.
• Perform risk management activities including pFMEA and process risk assessment.
• Support change management and revision of quality procedures.
• Manage product master data such as BOMs, specifications, routings, and inspection plans in ERP/PLM systems.
• Apply statistical analysis and process monitoring techniques for quality improvement.

Key Skills Required

• ISO 13485
• GMP / GxP Compliance
• Validation
• CAPA
• Risk Management
• pFMEA
• Root Cause Analysis
• Control Plan
• Audit Handling
• Statistical Analysis
• Change Management
• ERP / PLM Knowledge

Education & Experience

• Bachelors Degree in Mechanical, Biomedical, Chemical, Production Engineering, B.Pharm, or related field.
• 4-8 years of experience in Medical Device / Pharma / Regulated Manufacturing industry.
• Experience in Quality Engineering, Validation, or Regulatory Compliance preferred.