QA Manager

Texchem Corporation Sdn Bhd; Bayan Lepas; On-site; MYR 180,000 - 280,000; Full time

Job summary

KoniX (P) Sdn Bhd is seeking a dynamic Quality Manager to own the Quality Management System (QMS) and Environmental Management System (EMS). You will lead compliance, drive continuous improvement and partner with stakeholders to achieve the highest quality and regulatory standards.

The role requires strong leadership, 8–15 years in regulated manufacturing (medical device or healthcare), and hands-on expertise in ISO 13485, ISO 9001 and ISO 14001, with certification as an Internal/Lead Auditor.

Qualifications

• Bachelor's or Master's degree in Chemical Engineering or Quality Engineering or related engineering discipline.
• 8–15 years of experience in medical device, healthcare or regulated manufacturing.
• Strong knowledge of ISO 13485, ISO 9001 and ISO 14001 management systems.
• Certified Internal Auditor/Lead Auditor with experience in third-party audits.
• Proficient in quality management tools, QC techniques and continuous improvement.

Responsibilities

• Serve as Quality Management Representative (QMR) and Environmental Management Representative (EMR).
• Lead and maintain QMS and EMS with ISO standards and customer requirements.
• Manage QA and QC activities to ensure product quality and operational effectiveness.
• Monitor, analyse and report quality performance, non-conformities, corrective actions and improvements to Management.
• Plan, coordinate and lead internal audits, management reviews and external certification audits.
• Manage supplier/vendor qualification, assessment and performance monitoring.
• Liaise with customers, certification bodies on quality matters including contract reviews.
• Drive quality awareness, customer focus and CI initiatives.

Skills

Quality management

Auditing

Regulatory compliance

Leadership

Analytical skills

Stakeholder management

Communication skills

Education

Bachelor's in Chemical Engineering

Master's in Quality Engineering

Tools

ISO 13485

ISO 9001

ISO 14001

Auditing tools

Quality improvement tools

Job description

Hiring Company : KoniX (P) Sdn Bhd (formerly known as Texchem-Pack (PP) Sdn Bhd)

Role 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 Chemical Engineering, Quality Engineering, or related engineering discipline.

Minimum 8-15 years of experience, preferably in the medical device, healthcare or 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.

Unlock job insights

Hirer responsiveness Salary match Number of applicants

FMCG Manufacturing More than 10,000 employees

Texchem Group, headquartered in Penang, Malaysia, has evolved from a textile chemical trader in 1973 into a Malaysian multinational conglomerate with diverse business interests. Over five decades, we have grown through innovation, diversification, and continuous improvement, establishing operations across ASEAN and Japan.

Today, Texchem comprises five core business divisions: Industrial, Restaurant, Polymer Engineering, Food, and Venture Business. Guided by our vision to be the First Choice of People, we are committed to creating exceptional experiences for our people while delivering innovative solutions and sustainable growth for our stakeholders.

Texchem Group, headquartered in Penang, Malaysia, has evolved from a textile chemical trader in 1973 into a Malaysian multinational conglomerate with diverse business interests. Over five decades, we have grown through innovation, diversification, and continuous improvement, establishing operations across ASEAN and Japan.

Today, Texchem comprises five core business divisions: Industrial, Restaurant, Polymer Engineering, Food, and Venture Business. Guided by our vision to be the First Choice of People, we are committed to creating exceptional experiences for our people while delivering innovative solutions and sustainable growth for our stakeholders.

What can I earn as a Quality Assurance Manager