Assistant QMS Manager/Senior QMS Engineer

Job Purpose

The Assistant QMS Manager is responsible for establishing, maintaining, monitoring, and continuously improving the Company's Quality Management System (QMS) and Integrated Management System (IMS) to ensure compliance with applicable international standards, customer requirements, regulatory obligations, and corporate policies.

The role serves as the system owner for Quality Management System governance, internal audits, document control, ETQ administration, corrective and preventive actions (CAPA), management review, compliance monitoring, and continuous improvement initiatives. The incumbent shall support and maintain certification compliance for ISO 9001, ISO 13485, IATF 16949, ISO 14001, and ISO 45001 management systems.

Key Responsibilities

1. Quality Management System (QMS) Governance

• Establish, implement, maintain, and continuously improve the Company's Quality Management System (QMS) and Integrated Management System (IMS).
• Ensure compliance with the requirements of:
• ISO 9001 – Quality Management System
• ISO 13485 – Medical Device Quality Management System
• IATF 16949 – Automotive Quality Management System
• ISO 14001 – Environmental Management System
• ISO 45001 – Occupational Health & Safety Management System
• Act as custodian of the Integrated Management System and ensure system effectiveness across all business functions.
• Monitor management system performance and recommend improvement initiatives.
• Promote risk-based thinking, process ownership, and continual improvement throughout the organization.
• Ensure alignment between management systems, business objectives, and customer expectations.

2. Internal Audit Management

• Develop and maintain the annual Integrated Internal Audit Programme.
• Plan, schedule, coordinate, conduct, and lead internal audits across all departments and processes.
• Ensure audit activities comply with ISO audit principles and organizational requirements.
• Train, develop, and manage Internal Auditors to maintain auditor competency.
• Issue audit reports and monitor closure of audit findings.
• Verify effectiveness of corrective actions and preventive actions.
• Analyze audit trends and identify opportunities for systemic improvements.
• Maintain audit records and audit performance metrics.

3. External Audit & Certification Management

• Act as primary coordinator and management representative during:
• Certification Audits
• Surveillance Audits
• Re-certification Audits
• Customer Audits
• Regulatory Audits
• Supplier Assessments
• Coordinate audit preparation activities across departments.
• Ensure all audit findings are investigated, addressed, and closed within agreed timelines.
• Maintain certification status and ensure ongoing compliance with applicable standards.
• Liaise with certification bodies, customers, auditors, and regulatory authorities regarding quality system matters.

4. Document Control & Information Management

• Establish, implement, and maintain a comprehensive document control system.
• Ensure effective control of:
• Policies
• Quality Manuals
• Procedures
• SOPs
• Work Instructions
• Forms
• Specifications
• Engineering Documents
• Quality Records
• Environmental and Compliance Records
• Ensure documents are reviewed, approved, distributed, revised, retained, and archived according to established requirements.
• Manage document lifecycle control and revision management.
• Conduct periodic document reviews to ensure accuracy, effectiveness, and compliance.
• Standardize document templates, numbering systems, and document management practices.
• Ensure document retention and traceability requirements are met.

5. ETQ Administration & Digital Quality Systems

• Serve as System Administrator and Subject Matter Expert (SME) for ETQ.
• Manage and optimize ETQ modules including:
• Document Control
• CAPA
• Internal Audit
• Change Management
• Training Management
• Non-Conformance Management
• Complaint