QMS Engineer

Flex; Kulai; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading manufacturing partner is seeking a QMS Engineer located in Senai, Johor. This role involves conducting audits, monitoring CAPA processes, and ensuring compliance with ISO standards. Ideal candidates will have a degree in a related field and 4-5 years of experience in quality management systems.

Qualifications

• Minimum 4-5 years of working experience in the related field is required.

Responsibilities

• Assist to perform process/system audit.
• Monitor CAPA and assist in root cause analysis.
• Coordinate Quality Management Review and maintain audit records.

Skills

QMS

Education

Degree in related discipline or equivalent experience

Job description

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Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

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.

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

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

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.

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:

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