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Job Summary
To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a QMS Engineer located in Senai, Johor .
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.
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- 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
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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 accessibility@flex.com 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).