Document Control and Training Specialist 2

Dexcom; George Town; On-site; MYR 40,000 - 60,000; Full time

Job summary

A global health technology company in George Town, Malaysia is looking for a qualified individual to manage the change control system and support quality assurance. Candidates should have at least 2 years of experience, proficiency in Microsoft Office, and knowledge of electronic documentation systems. The role involves interacting with customers, preparing reports, and ensuring compliance with standards.

Qualifications

• Minimum of 2+ years of related experience.
• Ability to perform all essential duties satisfactorily.
• Understanding of Document Control requirements per ISO 13485 and 21 CFR Part 820.

Responsibilities

• Manage the change control system (Cloud PLM).
• Assist in Cloud PLM software training.
• Support quality assurance during audits.

Skills

Microsoft Office Suite

Critical thinking

Problem-solving

Knowledge of electronic documentation systems

Education

Postgraduate Diploma or Professional Degree in Business Studies, Administration, Management

Tools

Cloud PLM Document Control system

Job description

The Company

Dexcom Corporation (NASDAQ: DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Founded 25 years ago, Dexcom has pioneered an industry with a vision to change how diabetes is managed by providing personalized, actionable insights to improve health outcomes. Our mission is to continue improving human health on a global scale by developing innovative biosensing technologies and solutions for serious health conditions.

Our team is composed of passionate, ambitious individuals committed to earning customer trust through integrity, service, and dependability. We aim to become a leading consumer health technology company, expanding our solutions beyond diabetes care to broader health challenges.

Essential Duties And Responsibilities

• Manage the change control system (Cloud PLM), including reviewing, routing, assessing training impacts, and releasing change orders.
• Assist in Cloud PLM software training and other related training sessions.
• Ensure project completion is accurate and timely.
• Interact effectively with internal and external customers.
• Support quality assurance during external and internal audits.
• Monitor in-process document changes to ensure timely revisions.
• Assist customers with problem solving by applying knowledge and skills to a wide range of tasks.
• Scan, archive, and retrieve quality documents and records.
• Control and issue controlled and uncontrolled documents.
• Maintain service records across departments.
• Prepare requests for document reproduction.
• Ensure compliance with external standards in line with SOPs.
• Support documentation and configuration control procedures development.
• Assist in testing and improving change control and supporting software.
• Generate Quality Assurance reports as needed.
• Perform other duties as assigned.
• Ability to work in shifts.

Required Qualifications

• Ability to perform all essential duties satisfactorily.
• Minimum of 2+ years of related experience and/or training, or equivalent education and experience.
• Proficiency with Microsoft Office Suite.
• Ability to create reports supporting Quality Assurance systems.
• Strong critical thinking and problem-solving skills.
• Knowledge of electronic documentation systems.
• Understanding of Document Control requirements per ISO 13485 and 21 CFR Part 820.
• Ability to apply GDP and GMP knowledge to daily tasks.

Preferred Qualifications

• Experience with Cloud PLM Document Control system.

Education and Experience

• Postgraduate Diploma or Professional Degree in Business Studies, Administration, Management, or equivalent.

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