Overview

• Salary

  6,000 MYR ~ 7,000 MYR

• Industry

  Manufacturing(Machinery), Manufacturing(Pharmaceutical/Medical Equipment)

• Job Description

  - Assist with the establishment of a BU quality management system and ensuring compliance with all relevant Quality Standards, Directives and Regulations and ensure compliance in sites with regards to corporate policies and procedures.
  - Maintain records and files on all registrations of all existing Lifewave products in the territories. These include Medical Device, Food Supplement and Cosmetic product registrations.
  - Liaise with all competent authorities and registration bodies as required with regards to Medical Device, Food Supplement and Cosmetic product regulations.
  - Assist in the maintenance of and ensure compliance with the current and future quality systems in line with current and any changes or updates to regulatory requirements and industry best practices on a global basis.
  - Develop and deliver key training programs to enhance quality & regulatory awareness throughout the BU internal and contract facilities as required.
  - Liaise with BU facilities and keep informed of registration status and resulting on going requirements.
  - Manage document change order process for both internal and contract distribution organizations.
  - Actively support all design activities from initiation to full product release as per regulatory requirements.
  - Assist and participate in Internal / External Audit system and support in preparation and hosting of Third Party Audits including audit training, control room setup, general audit readiness throughout the business and post audit follow up.
  - Advise on the requirements of post market surveillance to relevant QMS / ISO system.
  - Drive / Participate / Support in quality improvement projects/activities.
  - Compile data for management reviews.
  - Support and manage vendors as required.
  - Perform other duties and responsibilities as assigned.