QMS Engineer

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 :

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).