QMS Engineer

Flex; Kulai; On-site; MYR 60,000 - 80,000; Full time

Job summary

A global manufacturing leader in Johor seeks a QMS Engineer to support quality management and compliance activities. The ideal candidate will have a degree in a related field, 4-5 years of relevant experience, and strong auditing skills. Responsibilities include monitoring CAPA, maintaining audit records, and ensuring GMP compliance. Join us to contribute to innovative product development in a collaborative environment.

Qualifications

• Minimum 4-5 years of working experience in the related field is required.
• Strong understanding of ISO 9001 and other relevant standards such as ISO 13485.
• Knowledge of techniques such as 5 Why’s, Fishbone Diagram, FMEA.

Responsibilities

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

Skills

QMS

Education

Degree in related discipline or equivalent experience

Job description

Overview

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.

Responsibilities

• Assist to perform process / system audit.
• Monitor CAPA and assist the department in root cause analysis and corrective actions of audit findings, tracking to resolution. (CA Type: Internal/External Audit/MR)
• Maintain audit records filing in file and FlexQ.
• Coordinate Quality Management Review by compiling MR slides, preparing MR agenda, sending meeting invitations, recording MR attendance and MR minutes, and uploading MR records in FlexQ-QDM-Management Review.
• Revise and upload Quality Objectives by compiling all targets from PIC after MR meeting.
• Assist Quality Manager to initiate and follow up on Corporate Initiatives and procedure deployment (Site Compliance Tracker, FlexQ Medical deployment, MQR).
• Revise related procedures and provide training accordingly.
• Assist to ensure GMP compliance culture and auditing program including corrective action process; provide training on Corporate Procedures and initiatives.
• Site Records Coordinator in Record Management Organization.
• Monitor records under RMS and Crown system.
• Ensure all Function Records Coordinators are trained.
• Have ISO Standard Knowledge – strong understanding of ISO 9001 and other relevant standards such as ISO 13485.
• Auditing Skills – internal auditing including planning, execution, reporting and follow-up.
• Process Mapping and Documentation – ability to develop, review and improve standard operating procedures, work instructions and Control Plans.
• Root Cause Analysis and Corrective Action (CAPA) – knowledge of techniques such as 5 Why’s, Fishbone Diagram, FMEA.
• Regulatory and compliance knowledge – understanding of applicable industry regulations and compliance requirements.

Qualifications

• Possesses a Degree in related discipline or equivalent experience.
• Minimum 4-5 years of working experience in the related field is required.
• Skills: QMS

Flex is an Equal Opportunity Employer and employment 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 are happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email [e-mail] for disability assistance. Note: this email does not accept resumes or applications. To be considered for a position at Flex, you must complete the application process first.