Senior Quality Engineer - Medical Devices QA Lead

ETI (M) SDN. BHD.; Seberang Perai; On-site; MYR 60,000 - 90,000; Full time

Job summary

ETI (M) SDN. BHD. seeks a Quality Assurance professional to establish, maintain and control processes in a medical manufacturing setting in Penang. You will partner with customers on quality plans, lead FAI reporting, and support audits while driving continuous improvement.

The role requires 2–3 years of QA experience in medical manufacturing, with familiarity in ISO9001/13485, IATF16949, SPC, FMEA, PPAP, APQP, Control Plan, and CAPA oversight.

Qualifications

• 2–3 years working experience in manufacturing quality assurance in Medical industry.
• Familiar with ISO9001, ISO13485, ISO14001, ISO45001, IATF16949.
• Experience in quality analysis, problem solving, and project management and customer audits.
• Experience in SPC, FMEA, PPAP, APQP, Control Plan, IQ, OQ, PQ, and MSA.
• Able to work independently with minimal supervision and show leadership.

Responsibilities

• Set and maintain quality plans with customers and ensure compliance.
• Lead and coordinate FAI reporting and customer audits at site.
• Drive continuous improvement on yield and quality metrics.
• Provide supervision to QA operators, technicians and inspectors.
• Guide engineers and technicians in responding to customer feedback and CAPA.

Skills

Quality assurance

Problem solving

Project management

Leadership

Customer interface

Tools

SPC

FMEA

PPAP

APQP

Control Plan

IQ/OQ/PQ

MSA

CNC Turning/Milling

Cold Heading

Job description

ETI (M) SDN. BHD. seeks a Quality Assurance professional to establish, maintain and control processes in a medical manufacturing setting in Penang. You will partner with customers on quality plans, lead FAI reporting, and support audits while driving continuous improvement.

The role requires 2–3 years of QA experience in medical manufacturing, with familiarity in ISO9001/13485, IATF16949, SPC, FMEA, PPAP, APQP, Control Plan, and CAPA oversight.