Engineering Change & Document Control Specialist

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 ·       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)

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