Flex QMS Engineer 

Malaysia, Johor 

919683319

located in

What a typical day looks like:

• Assist to perform process / system audit.
• Monitor CAPA and assists department in the root cause analysis and corrective actions ofaudits findings, tracking to resolution. (CA Type: Internal/External Audit/MR)
• Maintains audit records filing in file and FlexQ.
• Coordinate Quality Management Review by compiling MR slides, Prepare MR Agenda, domeeting invitation, taking MR attendance and MR minutes of meeting and upload all MR records in FlexQ-QDM-Management Review.
• Revise and upload Quality Objective by compiling all target from PIC after MR meeting.
• Assists Quality Manager to initiate and follow up Corporate Initiatives and procedure deployment. (Site Compliance Tracker, FlexQ Medical deployment, MQR)
• Revise related procedure and provides training accordingly.
• Assists to ensure a GMP compliance culture, and auditing program including corrective action process, Provide training on Corporate Procedures and initiatives.
• Site Records Coordinator in Record Managements Organization
• Monitor records under RMS and Crown system
• Ensure all Function records Coordinator is trained.
• ISO Standard Knowledge – Strong understanding of ISO 9001 and other relevant standards such as ISO 13485
• Auditing Skill – Internal auditing including planning, execution, reporting and follow-up
• Process Mapping and Documentation – Ability to develop, review and improve standard operating procedure, work instruction and Control Plan
• Root Cause Analysis and corrective action (CAPA) – knowledge on techniques such as 5 Why’s, Fishbone Diagram, FMEA
• Regulatory and compliance knowledge – understanding of applicable industry regulations and compliance requirement.

The experience we’re looking to add to our team:

• Possesses a Degree in related discipline or equivalent experience.
• Minimum 4-5 years of working experience in the related field is required
• Skill(s): QMS

Required Skills:

Optional Skills: