QA Engineer – Molded Plastics, ISO 9001/13485 Expert

Promooi Plastic Industries Sdn Bhd; Seberang Perai; On-site; MYR 67,000 - 112,000; Full time

Job summary

Promooi Plastic Industries Sdn Bhd is seeking a QA Engineer to develop, implement, and maintain quality systems for plastic injection molding. You will ensure products meet customer specs and ISO 9001 and ISO 13485 requirements, and support cross-functional teams in Production, Engineering, Tooling, Maintenance, and Supply Chain.

You will lead CAPA, SPC, MSA, FMEA, PPAP, and APQP activities, establish Control Plans, and drive continuous improvement to reduce defects and ensure regulatory

Qualifications

• Knowledge of ISO 9001:2015 quality management systems.
• Knowledge of ISO 13485:2016 medical device quality requirements.
• Experience with GMP and quality tools.

Responsibilities

• Develop and maintain quality systems for plastic injection molding.
• Ensure products meet customer specifications and regulatory standards.
• Collaborate with Production, Engineering, Tooling, Maintenance and Supply Chain.
• Drive continuous improvement and defect reduction.

Education

ISO 9001:2015

ISO 13485:2016

GMP

Tools

CAPA

SPC

MSA

FMEA (PFMEA/DFMEA)

PPAP

APQP

Control Plan

Job description

Promooi Plastic Industries Sdn Bhd is seeking a QA Engineer to develop, implement, and maintain quality systems for plastic injection molding. You will ensure products meet customer specs and ISO 9001 and ISO 13485 requirements, and support cross-functional teams in Production, Engineering, Tooling, Maintenance, and Supply Chain.

You will lead CAPA, SPC, MSA, FMEA, PPAP, and APQP activities, establish Control Plans, and drive continuous improvement to reduce defects and ensure regulatory