Quality Assurance Manager

KoniX (formerly known as Texchem Polymer Engineering); Bayan Lepas; On-site; MYR 180,000 - 280,000; Full time

Job summary

KoniX, located in Bayan Lepas, Penang, Malaysia, seeks an experienced Quality Manager to own the Quality Management System (QMS) and Environmental Management System (EMS). You will drive compliance, operational excellence and continuous improvement, collaborating with stakeholders to uphold the highest standards of quality and customer satisfaction.

Responsibilities include leading QA/QC activities, coordinating internal and external audits, managing supplier qualification, and liaising with

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering, Quality Engineering or related field.
• 8–15 years of experience in semiconductor or medical device/regulated manufacturing preferred.
• Strong knowledge of ISO 13485, ISO 9001 and ISO 14001.
• Certified Internal Auditor/Lead Auditor with third‑party audit experience.
• Proficient in quality management tools and continuous improvement methods.

Responsibilities

• Serve as the Quality Management Representative (QMR) and Environmental Management Representative (EMR).
• Lead and maintain the Quality Management System (QMS) and Environmental Management System (EMS).
• Oversee QA and QC activities to ensure product quality and operational effectiveness.
• Monitor quality performance, non-conformities and corrective actions; report to Management.
• Coordinate internal audits, management reviews and external certification audits.
• Manage supplier qualification, assessment and performance monitoring.

Skills

Quality management

ISO auditing

Leadership

Stakeholder mgmt

Problem solving

Regulatory compliance

Education

Mechanical/Quality Engineering degree

Master’s preferred

Tools

Quality tools

Audit software

Job description

We are seeking a dynamic and experienced Quality Manager to take ownership of our Quality and Environmental Management Systems. In this high-impact role, you will drive compliance, operational excellence and continuous improvement, while partnering with stakeholders across the organisation to ensure the highest standards of quality, regulatory compliance and customer satisfaction.

Responsibilities

• Serve as the appointed Quality Management Representative (QMR) and Environmental Management Representative (EMR).
• Lead and maintain the company's Quality Management System (QMS) and Environmental Management System (EMS), ensuring compliance with ISO standards, regulatory and customer requirements.
• Manage all Quality Assurance (QA) and Quality Control (QC) activities to ensure product quality and operational effectiveness.
• Monitor, analyse and report quality performance, non-conformities, corrective actions and improvement initiatives to Management.
• Plan, coordinate and lead internal audits, management review meetings and external certification audits.
• Manage supplier/vendor qualification, assessment and performance monitoring programmes.
• Liaise with customers, certification bodies and relevant stakeholders on quality-related matters, including contract reviews and quality requirements.
• Drive quality awareness, customer focus and continuous improvement initiatives across the organisation.

Requirements

• Bachelor's Degree or Master’s Degree in Mechanical Engineering, Quality Engineering, or related engineering discipline.
• Minimum 8-15 years of experience, preferably in the semiconductor or medical device / related regulated manufacturing industry.
• Strong knowledge and hands‑on experience in ISO 13485, ISO 9001 and ISO 14001 management systems.
• Certified Internal Auditor/Lead Auditor with experience leading and participating in third‑party audits.
• Proficient in quality management tools, quality control techniques and continuous improvement methodologies.
• Strong leadership, analytical, problem‑solving and stakeholder management skills.
• Excellent communication skills with the ability to engage customers, auditors and cross‑functional teams.