- Location
- MY JB Tebrau, Malaysia
- Type
- Full-time
- Education
- Certification
- Source
- Workday
Description
About the Role
We are seeking a detail-oriented and motivated Document Control Specialist to join our Document Control team. This role is critical in ensuring that our document control systems support regulatory compliance, product quality, and business operations.
You will play a key role in managing change processes, maintaining document integrity, and supporting Quality Management Systems (QMS) across the organization globally. This is a great opportunity for someone who thrives in a regulated environment and enjoys working with cross-functional teams.
Key Responsibilities
Implement and maintain document control processes aligned with Quality Management Systems across the organization.
Manage Change Notices, ensuring timely and accurate documentation of product and process changes in the electronic document management system and the ERP system (Oracle)
Coordinate with engineering, manufacturing, regulatory, and marketing teams and other areas as needed to ensure changes are properly documented and communicated
Maintain document accuracy, version control, and traceability across systems
Support regulatory compliance requirements.
Ensure documentation systems are audit-ready and compliant with internal policies and external regulations
Assist in internal and external audits, including preparation and follow-up activities
Identify opportunities for process improvements and support continuous improvement initiatives
Maintain secure and accurate record-keeping systems
About You
Experience in document control, quality assurance, or regulated environments (medical device/pharma preferred)
Familiarity with QMS and regulatory standards (e.g., ISO 13485, GMP, FDA requirements) is highly desirable
Knowledge of engineering change management processes (ECN/ECR)
Strong attention to detail and organizational skills
Ability to manage multiple tasks and work independently
Strong communication skills with the ability to collaborate across teams
Comfortable working with document management systems and digital tools
Vocational training or equivalent experience in a relevant field
What You’ll Bring
A proactive and solution-focused mindset
Ability to act as a subject matter resource for document control processes
Strong commitment to quality, compliance, and accuracy
Continuous improvement mindset
Why Join Us?
Be part of a collaborative and supportive Quality Assurance team
Work in a role that directly impacts product quality and compliance
Opportunity to contribute to global quality systems and processes
Career growth and professional development opportunities
Apply Now
If you are passionate about quality, compliance, and process excellence, we would love to hear from you. Submit your application today!
#LI-APAC
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.