QMS Engineer

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives. 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.

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

• Site
  
  

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and 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 [email protected] 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).