Engineering Change & Document Control Specialist (Medical Devices)

Position Title: Engineering Change & Document Control Specialist (Medical Devices)
Experience: 5–10 Years
Location: India - Remote
Work Hours: US Shift Hours

Job Summary

We are seeking an experienced Engineering Change & Document Control Specialist with a strong background in the medical device industry. The ideal candidate will bring hands-on expertise in managing Engineering Change Orders (ECOs), design documentation, and capital equipment change processes, while ensuring compliance with regulatory and quality standards.

Key Responsibilities

• Manage and process ECOs and change requests in line with quality and regulatory requirements.
• Maintain and control design and technical documentation (drawings, specs, BOMs, DHF, DMR, etc.).
• Coordinate change approvals and implementations with Engineering, Quality, Manufacturing, and Supply Chain teams.
• Handle POs and change orders for capital equipment, including tracking, vendor coordination, and documentation.
• Ensure proper version control, traceability, and audit readiness of all records.
• Support internal and external audits related to document control and change management.
• Collaborate with global teams with at least 6 hours overlap with US EST.

Required Qualifications

• 5–10 years of experience in medical device engineering/operations.
• Strong hands-on experience with ECOs, document control, and change management.
• Experience handling capital equipment change orders and POs.
• Solid knowledge of FDA QSR, ISO 13485, and change control best practices.
• Proficiency with PLM/EDMS systems (Windchill, Agile, Arena, or similar).
• Excellent documentation, coordination, and communication skills.

Preferred Skills

• Experience supporting product development or manufacturing changes.
• Familiarity with DHF/DMR, risk management, and design control requirements.
• Ability to work independently with global cross-functional teams.

All your information will be kept confidential according to EEO guidelines.