Engineering Change & Document Control Specialist

Job Description

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)