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 recent 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.

Client industry you are hiring for Medical Devices Equipment

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