QA Manager

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

1. Serve as the appointed Quality Management Representative (QMR) and Environmental Management Representative (EMR).
2. Lead and maintain the company's Quality Management System (QMS) and Environmental Management System (EMS), ensuring compliance with ISO standards, regulatory and customer requirements.
3. Manage all Quality Assurance (QA) and Quality Control (QC) activities to ensure product quality and operational effectiveness.
4. Monitor, analyse and report quality performance, non-conformities, corrective actions and improvement initiatives to Management.
5. Plan, coordinate and lead internal audits, management review meetings and external certification audits.
6. Manage supplier/vendor qualification, assessment and performance monitoring programmes.
7. Liaise with customers, certification bodies and relevant stakeholders on quality-related matters, including contract reviews and quality requirements.
8. 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.