Engineering Change & Document Control Specialist (Medical Devices)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Position Title: Engineering Change & Document Control Specialist (Medical Devices)
Experience: 510 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
- 510 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
Yes
Employment Type :
Contract
Key Skills
About Company
At Fusion Plus Solutions Inc, we believe that it’s an exceptional company - a company of people proud of the work they do and the solutions they provide. By understanding what drives our specialty industries, becoming involved in our communities on a professional and personal basis, f ... View more
