Engineering Change & Document Control Specialist

**Job Title - Engineering Change & Document Control Specialist (Medical Devices)

• Remote (India)**

**India

• Remote**

Must have minimum 6 hours overlap with US EST

Experience: 5–10 Years

Job Description

We are looking for an experienced Engineering Change & Document Control Specialist with strong medical device industry experience.

Responsibilities:

·       Manage and process ECOs / Change Requests

·       Maintain controlled documents (Drawings, Specs, BOM, DHF, DMR)

·       Coordinate approvals with Engineering, Quality, Manufacturing, and Supply Chain

·       Support capital equipment change orders & POs

·       Ensure version control, traceability, and audit readiness

·       Support internal/external audits

Requirements:

·       5–10 years in Medical Devices

·       Strong hands-on experience in ECO + Document Control + Change Management

·       Knowledge of FDA QSR & ISO 13485

·       Experience with PLM/EDMS tools (Windchill / Agile / Arena or similar)