QA Manager: QMS/EMS Leader (ISO Expert)

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

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.