Document Control and Training Specialist 1

6 days ago

Batu Kawan, Penang, Malaysia Dexcom Full time

Position Summary:

This position is responsible for maintaining and sustaining the change control system and supporting all Document Control activities in accordance with Dexcom's processes, 21 CFR Part 820 and ISO Intermediate to proficient in Microsoft office is a must for this position. Intermediate in generating reports to support other Quality Assurance systems. The ability to use critical thinking and resolve issues is required. A highly driven, detailed oriented person is essential for this position.  Knowledge of electronic documentation systems is required. Must have the ability to apply acquired knowledge of GDP and GMP to daily tasks.

Essential Duties and Responsibilities:

  • Manage the change control system (Agile/Cloud PLM); Review, route, assess training impact and release change orders
  • Support the establishment and improvement of quality systems and facilitate continuous quality improvements in Dexcom's continuous efforts to improve the Quality System
  • Generate/Present QA reports as needed and coordinate data to be presented in Gemba reports
  • Assist in Agile/Cloud PLM software/Quality training and other training as required
  • Monitoring status of in-process document changes to ensure timely revisions
  • Able to positively interact with internal and external customers
  • 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
  • Support Quality in both external and internal audits
  • Maintain record integrity through archiving and retrieval of quality and departmental records
  • Issues controlled and uncontrolled documents
  • Prepare requests for reproduction of documents
  • Maintain external standards in accordance with standard operating procedures
  • Independently work on moderately difficult assignments with minimal guidance but have the ability to organize results to be presented and understood by Management
  • Support the testing and improvement of the change control software and other supporting software
  • Support manufacturing operations by creating, processing, distributing and controlling revisions of all manufacturing documentation
  • Support the development of documentation and configuration control procedures
  • This position assumes and performs other duties as assigned.

Required Qualifications:

  • Minimum of at least 1+ years recent experience in Quality Systems is required
  • Knowledge of all aspects of documentation control and Change order process
  • Aptitude for detail, accuracy and excellent organization skills, knowledge of PC based programs such as: Microsoft Word, MRP system, Excel and data input
  • Ability to create and present reports in support of Quality Assurance systems
  • A high capacity to use critical thinking and resolve issues are required
  • Understanding of Document Control requirements and processes as outlined in ISO 13485 and 21 CFR part 820 or equivalent.
  • Ability to apply and educate others of acquired knowledge of GDP and GMP to daily task
  • Able to work on shift.

Experience and Education Requirements:

  • Typically requires 0-2 years of related experience and a High school diploma/certificate or equivalent.

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