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Infineon Technologies (Malaysia) Sdn Bhd, Melaka, is seeking a Senior QMS Engineer to lead the design, implementation and continuous improvement of the ISO 9001 QMS, ensuring regulatory and customer requirements are met.
You will drive internal and supplier audits, CAPA, risk management, and cross‑functional quality initiatives to raise product quality and process effectiveness.
The Senior QMS Engineer is responsible for developing, implementing, maintaining, and continuously improving the organization's Quality Management System (QMS) to ensure compliance with ISO 9001, regulatory requirements, customer expectations, and internal quality standards. The role leads QMS activities, internal and external audits, corrective and preventive actions (CAPA), risk management, supplier quality support, and continuous improvement initiatives. The Senior QMS Engineer also drives quality awareness across the organization, provides guidance to junior quality personnel, and works closely with cross-functional teams to improve product quality, process effectiveness, and operational efficiency.
Develop, implement, maintain, and improve QMS processes and documentation in accordance with ISO 9001 and applicable requirements.
Plan and conduct internal audits and coordinate customer, certification, and regulatory audits.
Lead non-conformance investigations, CAPA, and root cause analysis, and verify corrective action effectiveness.
Drive continuous improvement and quality improvement initiatives using Lean and Six Sigma methodologies.
Monitor quality KPIs and provide analysis and reports to support management decision-making and management reviews.
Support quality risk assessment, quality planning, and compliance activities.
Monitor supplier quality performance and support supplier audits, qualification, and corrective actions.
Conduct QMS and quality-related training and promote quality awareness across the organization.
Mentor junior quality personnel and work with cross-functional teams to resolve quality issues and improve processes.
Strong knowledge of QMS and ISO 9001 requirements.
Strong skills in quality auditing, CAPA, root cause analysis, and problem-solving.
Working knowledge of FMEA, SPC, Control Plans, and process capability.
Knowledge of Lean Six Sigma and continuous improvement methodologies.
Good data analysis and reporting skills; proficiency in Minitab or equivalent tools is an advantage.
Strong communication, stakeholder management, and cross-functional collaboration skills.
Diploma or Bachelor's Degree in Engineering, Quality Management, or a related discipline.
6–10 years of relevant experience in Quality Assurance, Quality Engineering, or QMS.
Hands-on experience in ISO 9001 QMS implementation, maintenance, and auditing.
Experience in CAPA, non-conformance management, root cause analysis, and quality improvement.
Experience in supplier quality and external audit coordination is an advantage.
ISO 9001 Lead Auditor certification is preferred.
ASQ Certified Quality Engineer (CQE) and/or Lean Six Sigma certification is an advantage.
Good command of written and spoken English.
Working Day: Mon to Fri
Infineon Technologies (Malaysia) Sdn Bhd
Melaka, MY