Document Control jobs in Malaysia

Penang, Malaysia

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

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-13485. 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.

• You manage the change control system (Agile/Cloud PLM); review, route, assess training impact, and release change orders.
• You support the establishment and improvement of quality systems and facilitate continuous quality improvements in Dexcom’s continuous efforts to improve the Quality System.
• You generate and present QA reports as needed and coordinate data to be presented in Gemba reports.
• You assist in Agile/Cloud PLM software/Quality training and other training as required.
• You monitor the status of in-process document changes to ensure timely revisions.
• You interact positively with internal and external customers.
• You assist customers with problem solving and offer possible solutions utilizing your understanding of the job and applying knowledge and skills to complete a wide range of tasks.
• You support Quality in both external and internal audits.
• You maintain record integrity through archiving and retrieval of quality and departmental records.
• You issue controlled and uncontrolled documents.
• You prepare requests for reproduction of documents.
• You maintain external standards in accordance with standard operating procedures.
• You work independently on moderately difficult assignments with minimal guidance but have the ability to organize results to be presented and understood by Management.
• You support the testing and improvement of the change control software and other supporting software.
• You support manufacturing operations by creating, processing, distributing, and controlling revisions of all manufacturing documentation.
• You support the development of documentation and configuration control procedures.
• You assume and perform other duties as assigned.

• You have a minimum of 1+ years of recent experience in Quality Systems.
• You typically require 0–2 years of related experience and a High school diploma/certificate or equivalent.
• You possess knowledge of all aspects of documentation control and the change order process.
• You demonstrate aptitude for detail, accuracy, and excellent organization skills, along with knowledge of PC-based programs such as Microsoft Word, MRP systems, Excel, and data input.
• You have the ability to create and present reports in support of Quality Assurance systems.
• You bring a high capacity for critical thinking and issue resolution.
• You understand Document Control requirements and processes as outlined in ISO 13485 and 21 CFR Part 820 or equivalent.
• You apply and educate others on acquired knowledge of GDP and GMP in daily tasks.
• You are able to work on shift.

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

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