Quality & Risk Leader: QMS, Sustainability & Outsourced Services

Sterile Services Sdn Bhd; Malaysia; On-site; MYR 180,000 - 280,000; Full time

Job summary

Sterile Services Sdn Bhd is seeking a Quality Management Lead to steward its QMS, risk management and sustainability programs in Malaysia. The role focuses on ISO 9001 and ISO 13485 maintenance, audit support, CAPA, and governance to ensure service quality and regulatory compliance across outsourced services.

You will coordinate with operations, logistics and vendors to drive continuous improvement, strengthen governance, and deliver performance metrics, audits, and stakeholder satisfaction.

Qualifications

• Relevant experience in Quality Management Systems, Healthcare Management, compliance, sterilization or other regulated industries.
• Practical experience in ISO 9001 and ISO 13485 implementation and maintenance.
• Knowledge of risk management, FMEA, CAPA and internal auditing.
• Good analytical, communication and problem-solving skills.

Responsibilities

• Lead and manage SSSB's QMS, risk management, sustainability and outsourced service governance.
• Plan, coordinate and support audits, CAPA and corrective actions.
• Monitor KPIs and process performance against requirements, ensuring compliance.
• Oversee outsourced logistics and housekeeping service performance and governance.
• Drive continuous improvement and sustainable performance across the organization.
• Prepare management reports and support governance, risk, and continuity initiatives.

Skills

Quality Management Systems experience

Healthcare Management

Compliance

Sterilization

Regulated industries

Analytical skills

Communication skills

Problem-solving skills

Job description

Sterile Services Sdn Bhd is seeking a Quality Management Lead to steward its QMS, risk management and sustainability programs in Malaysia. The role focuses on ISO 9001 and ISO 13485 maintenance, audit support, CAPA, and governance to ensure service quality and regulatory compliance across outsourced services.

You will coordinate with operations, logistics and vendors to drive continuous improvement, strengthen governance, and deliver performance metrics, audits, and stakeholder satisfaction.