Quality Systems Specialist

2 weeks ago

Kulim, Kedah, Malaysia AMS Full time 90,000 - 120,000 per year

Quality Systems Specialist

Join a transformative MedTech player, poised to expand in Malaysia and shape the region's healthcare ecosystem.

In this exciting role as a Quality Systems Specialist for Document Control, you will play a crucial part in ensuring regulatory compliance by managing company documents and overseeing document control systems. This role includes preparing for audits, maintaining documentation integrity, and training employees in document control processes. Reporting to the Quality Manager, this position contributes to the organization's commitment to quality and continuous improvement.

About this role:

As a Quality Systems Specialist for Document Control, reporting to the Quality Manager, you will be responsible for ensuring regulatory compliance by managing company documents and overseeing document control systems. You will be preparing for audits, maintaining documentation integrity and training employees on document control process. This is an exciting position in which you will be directly contributing to the company's commitment to quality and continuous improvement.

Your responsibilities may include:

  • Managing document control systems to ensure regulatory compliance.
  • Preparing and supporting audits by maintaining accurate documentation.
  • Training employees on document control processes and systems.
  • Collaborating with cross-functional teams to ensure document integrity.
  • Identifying opportunities for process improvements and implementing solutions.
  • Ensuring attention to detail in all documentation-related tasks.
  • Communicating with internal teams to resolve issues and maintain compliance.
  • Supporting the development and execution of quality system initiatives.

Essential skills and experience:

  • Bachelor's degree in a relevant field.
  • 3+ years of experience in technical document control or a related function.
  • Knowledge of ISO 13485 quality management system requirements must be demonstrated.
  • Fluency in English, with strong reading and writing skills
  • Travel Requirements: International travel of approximately 25% may be required during the transfer project, to interact with the sending site team and support key transfer activities at both sending and receiving sites. The role therefore requires a valid passport and a willingness to travel, including undertaking extended overseas assignments as needed.

Desirable skills and experience:

·       Familiarity with regulatory standards and audit preparation.

·       Strong attention to detail and organisational skills.

·       Previous experience in employee training and cross-functional collaboration.

What's in it for you:

This role offers innovative projects, strong culture, career progression and a great work-life balance. Additionally, it's an opportunity to be part of a transformative greenfield project that will contribute to our client's ongoing commitment to improving healthcare globally while supporting local communities in Malaysia.

We offer a competitive package including salary, incentives, medical coverage and paid leave.

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