Job Title - Engineering Change & Document Control Specialist (Medical Devices) – Remote (India)
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
· Robust 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)