Senior Quality Assurance & Compliance Lead (ISO/GMP)

Ominent Sdn.Bhd.; Shah Alam; On-site; MYR 60,000 - 90,000; Full time

Job summary

IGL Coatings is a multi-award winning Malaysian technology firm based in Shah Alam, focused on nanotechnology coatings. The role leads QMS, audits, CAPA, and lab testing to ensure product quality and regulatory compliance across materials and finished goods.

Responsibilities include collaborating with Production, R&D, and Procurement to drive improvements, reduce defects, and maintain compliance with ISO 9001 and GMP.

Qualifications

• Experience implementing and maintaining QMS (ISO 9001, GMP).
• Proven ability to lead internal and external audits and keep SOPs up to date.
• Strong root cause analysis, CAPA planning and effectiveness tracking.
• Experience with laboratory testing across raw materials to finished products.
• Ability to develop and validate testing methods and calibrate equipment.
• Data-driven mindset to identify quality improvements and cost savings.
• Experience with customer and supplier quality management.

Responsibilities

• Develop, maintain, and improve the QMS in compliance with ISO 9001, GMP, customer requirements, and applicable regulations.
• Lead internal audits, support external audits, and ensure quality documents such as SOPs, specifications, checklists, and quality records are properly maintained and updated.
• Lead investigations of quality issues, non-conformances, and deviations through RCA, implement CAPA, and monitor corrective action effectiveness.
• Oversee the inspection and testing of raw materials, in-process samples, and finished products to ensure compliance with specifications.
• Develop and validate testing methods, manage calibration/validation of laboratory equipment, and ensure accuracy and traceability of results.
• Analyze quality data and trends, identify opportunities, and collaborate with Production, R&D, Procurement to improve product consistency and reduce defects.
• Lead customer complaint investigations and work with suppliers to ensure incoming materials meet requirements.

Skills

QMS

Audits

CAPA RCA

Quality Docs

Lab Testing

Analytical Methods

Process Improvement

Supplier Quality

Tools

Laboratory Equipment

Calibration Instruments

Job description

IGL Coatings is a multi-award winning Malaysian technology firm based in Shah Alam, focused on nanotechnology coatings. The role leads QMS, audits, CAPA, and lab testing to ensure product quality and regulatory compliance across materials and finished goods.

Responsibilities include collaborating with Production, R&D, and Procurement to drive improvements, reduce defects, and maintain compliance with ISO 9001 and GMP.