Document Control and Training Specialist 2

2 weeks ago


Penang, Malaysia Dexcom Full time

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

**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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