Document Control Specialist
4 days ago
EMERALD MEDICAL SERVICES PTE. LTD. is seeking a highly skilled Document Control Specialist to join our team in ensuring compliance with regulatory requirements and maintaining accurate documentation.
About the RoleThis position plays a critical role in supporting our Quality function by reviewing all documents, including LHRs, Inspection Reports, and Shipment Reports. The ideal candidate will have experience in creating Engineering Change Order (ECO) packets, reviewing and maintaining quality reports, and ensuring the current revision of controlled documents is clearly defined.
The successful candidate will also be responsible for training relevant personnel on documentation standards and practices, as well as reviewing and approving suppliers of components, raw materials, products, and services that affect product quality.
Responsibilities- Support Quality function in reviewing all documents
- Create and review ECO packets for compliance
- Maintain accuracy and integrity of quality reports
- Ensure timely removal of obsolete documents
- Train personnel on documentation standards and practices
- Review and approve supplier qualifications
To be successful in this role, you will need:
- Diploma or similar field with minimum 3 years of progressive Document Control responsibility
- Medical Device Manufacturing experience with knowledge of catheter production techniques preferred
- Strong Quality Skills and Engineering background desirable
- Knowledge of GMPs, ISO 13485, and Medical Device Directives
- Expertise in Microsoft Word, Excel, and PowerPoint
This role will be based in a controlled environment (Class 100K cleanroom) and office area. You will work closely with all levels of Company personnel and be required to travel occasionally.
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