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QMS Engineer

QMS Engineer

FlexJohor, Malaysia
30+ hari lalu
Penerangan pekerjaan

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a 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 of audits 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, do meeting 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
  • NS27

    FA22

    LI-NI1

    Job Category

    Quality

    Required Skills : Optional Skills :

    Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on : age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and we'll discuss your specific situation and next steps (NOTE : this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).

    Buat amaran kerja untuk carian ini

    Engineer • Johor, Malaysia