Document Control and Training Specialist 2

1 week ago


Simpang Ampat, Malaysia Dexcom Full time

**Essential Duties and Responsibilities**:

- Manage the change control system (Cloud PLM); Review, route, assess training impact and release change orders
- Assist in Cloud PLM software training and other training as required
- Ensure projects are completed accurately and on time
- Able to interact with internal and external customers
- Support Quality in both external and internal audits
- Monitoring status of in-process document changes to ensure timely revisions
- Assist customers with problem solving and offer possible solutions utilizing understanding of the job and applies knowledge and skills to complete a wide range of tasks
- Scan, archive and retrieve quality documents and records
- Issues controlled and uncontrolled documents
- Maintain service records of all departments
- Prepare requests for reproduction of documents
- Maintain external standards in accordance with standard operating procedures
- Support the development of documentation and configuration control procedures
- Support the testing and improvement of the change control software and other supporting software
- Generate Quality Assurance reports as needed
- This position assumes and performs other duties as assigned
- Able to work in shift

**Required Qualifications**:

- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily
- Minimum of 2+ years related experience and/or training; or equivalent combination of education and experience
- Proficient with Microsoft Office Suite
- Ability to create reports in support of other Quality Assurance systems
- Ability to use critical thinking and resolve issues
- Knowledge of electronic documentation systems
- Good understanding of Document Control requirements and processes as outlined in ISO 13485 and 20 CFR part 820

**Preferred Qualifications: (Optional)**
- Experience with Cloud PLM Document Control system

**Experience and Education Requirements**:

- High school diploma or general education degree (GED)



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