Job Description

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Client Background: MNC Company

Industry : Manufacturing

Location: Johor Bahru & Senai

Headcount: 1

Position Title : Quality System Manager

Tenure: Permanent

Remuneration: RM10,000 - RM20,000

Responsibilities

Job Overview

Responsible for quality system management, ensuring that the company\'s quality management system is established, implemented and maintained as required; ensuring that all company employees are aware of the importance of meeting regulatory and customer requirements; reporting to the general manager on the operation of the quality management system, quality improvement suggestions and investment requirements; representing the company in external contacts on quality management system matters.

• Develop annual quality management system work plans and monitor their implementation;
• Plan and form written system documents according to the requirements of the quality management system;
• Organize quality system document training and guide departments to establish and improve the quality management system;
• Revise and improve quality management system documents;
• Compile internal audit and management review implementation plans and assist in organizing internal audit and management review;
• Compile internal audit reports and management review reports, issue rectification plans and verify the rectification effects;
• According to the second and third party audit plans, guide the audit preparation and audit arrangements, guide the departments to rectify and verify the non-conformities found in the audits, and collect and compile non-conformity reports and rectification materials;
• Regularly supervise and inspect the operation of the department management system and report to the superior, monitor the quality performance index of monthly performance appraisal, and track the implementation effect of the department rectification plan;
• Assist departments in inspecting and supervising the implementation of relevant management systems;
• Assist leaders in supervising the distribution, recovery, invalidation of all controlled documents.

Requirement

• College degree or above, more than 3 years of working experience in the medical device related industry;
• Adhere to disciplines and laws, have good professional ethics and no bad work records;
• Familiar with and properly implement relevant national laws, regulations and rules. Received training in relevant laws and standards of medical devices;
• Hold the auditor certificate of YY/T 0287 (ISO 13485) or GB/T19001 (ISO9001), or received systematic quality management system knowledge training of the same level;
• Familiar with and have the ability to guide or supervise the departments of the company to implement the \xe2\x80\x9cMedical Device Production Quality Management Standard\xe2\x80\x9d in accordance with the regulations;
• Have good organizational, communication and coordination skills;
• To special talents the requirements can be reduced, which shall be approved by the general manager.

Sub Specialization : Others;Any
Type of Employment : Permanent
Minimum Experience : 5 Years
Work Location : Johor
Salary Range : RM10,000 - RM20,000

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