Coordinates and supports individual audits: prepare audit and documentation, organization logistics, audit progress and follow-ups, communicate between auditors and departments (focus: administration)
Job Summary
The role is responsible for end-to-end administrative and operational support for medical device certification and QMS-related processes, including application handling, certificate issuance, customer communication, documentation control, and invoicing, using internal systems.
Key Responsibilities
1. Quotation & Customer Support
- Receive quotation requests via email
- Prepare, review, and file quotations; submit for approval
- Respond to customer inquiries via email
2. Application Handling & Documentation
- Receive and register application documents
- Maintain logs, filing, scanning, and system data entry
- Manage unassigned applications
3. Certificate Issuance
- Assign certification numbers and maintain registers
- Input and update certification data in internal systems
- Coordinate certification review and decision processes
- Issue and dispatch certificates and standards conformity documents
4. QMS Operations (Renewal & Surveillance)
- Handle QMS applications and audit documentation
- Replace and manage audit documents
- Coordinate with auditors
- Prepare and send conformity certificates and surveillance reports
5. Minor Change, Succession & Withdrawal
- Process minor changes and succession notifications
- Issue confirmation letters and update records
- Handle certification organization and withdrawal procedures
6. Invoicing, Surveys & Records Management
- Issue and send invoices
- Distribute and compile on-site audit surveys
- Manage archived documents and monthly filing
Required Qualifications
- Experience in administrative or operational roles
- High attention to detail in document and data management
- Strong written communication skills
Preferred Qualifications
- Experience in medical device, certification, or QMS-related fields
- Experience using business systems such as Salesforce