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 Management

  • Risk Management

  • Supplier Quality Management

• Configure workflows, notifications, dashboards, and automated reports.

• Monitor ETQ system utilization and compliance.

• Coordinate ETQ system upgrades, validation activities, user access management, and change implementation.

• Provide user training and technical support for ETQ users.

• Lead digitalization and automation initiatives related to quality management processes.

6. Corrective & Preventive Action (CAPA) Management

• Manage the organization's CAPA programme.

• Facilitate investigation of:

  • Customer Complaints

  • Internal Non-Conformities

  • Audit Findings

  • Process Deviations

  • Supplier Quality Issues

• Lead root cause analysis activities using methodologies such as:

  • 8D

  • 5 Why

  • Fishbone Diagram

  • FMEA

  • Pareto Analysis

• Monitor CAPA implementation, effectiveness verification, and closure.

• Analyze recurring issues and drive preventive improvement actions.

7. Change Management & Risk Management

• Administer and monitor management system change control processes.

• Ensure all process, product, system, and documentation changes are appropriately assessed and approved.

• Facilitate risk assessments associated with operational and quality system changes.

• Support implementation of risk-based thinking and risk management methodologies across the organization.

• Monitor risk registers and mitigation plans.

8. Training & Competency Management

• Develop and maintain annual QMS and compliance training programmes.

• Conduct training related to:

  • Quality Management Systems

  • Internal Auditing

  • Document Control

  • ETQ Usage

  • CAPA Management

  • Compliance Requirements

• Monitor training completion and competency effectiveness.

• Maintain training records and competency matrices.

• Support department managers in identifying competency development requirements.

9. Management Review & Compliance Reporting

• Coordinate Management Review Meetings.

• Prepare management review reports and performance summaries.

• Consolidate and analyze:

  • Audit Results

  • CAPA Performance

  • Customer Complaints

  • Process KPIs

  • Training Compliance

  • ETQ Utilization

  • Quality Objectives

• Present management system performance data and recommendations for improvement.

• Monitor progress of management review action items.

10. Continuous Improvement & Operational Excellence

• Lead and facilitate continuous improvement projects related to management systems and business processes.

• Drive process standardization, waste reduction, and system optimization initiatives.

• Support Lean Manufacturing, Six Sigma, Operational Excellence, and Digital Transformation programmes.

• Benchmark industry best practices and implement suitable improvements.

• Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization.

11. Quality KPI Management

• Establish and monitor QMS performance indicators.

• Analyze quality trends and compliance metrics.

• Prepare monthly, quarterly, and annual reports for management review.

• Monitor:

  • Audit Performance

  • CAPA Closure Rate

  • Training Compliance

  • Document Review Compliance

  • ETQ Utilization

  • Customer Complaint Trends

  • Quality Objective Achievement

• Recommend actions to improve organizational performance and compliance.

Qualifications

• Degree or Diploma in Quality Management, Engineering, Manufacturing, Industrial Engineering, Business Management, or related discipline.

• ISO 9001 Lead Auditor Certification preferred.

• ISO 13485 Internal Auditor or Lead Auditor Certification preferred.

• IATF 16949 Internal Auditor Certification preferred.

• ISO 14001 Internal Auditor Certification preferred.

• ISO 45001 Internal Auditor Certification preferred.

• Lean Six Sigma Green Belt certification is an advantage.

Experience

• Minimum 5–8 years of experience in Quality Management Systems, Compliance, Quality Assurance, or Integrated Management Systems within a manufacturing environment.

• Experience supporting or managing multiple ISO certification systems.

• Hands-on experience with ETQ or equivalent Electronic Quality Management Systems (eQMS).

• Experience leading internal and external audits.

• Strong knowledge of document control, CAPA, change management, risk management, and continuous improvement methodologies.

Competencies

• Strong knowledge of ISO 9001, ISO 13485, IATF 16949, ISO 14001, and ISO 45001 requirements.

• Excellent audit management and compliance knowledge.

• Strong analytical and problem-solving skills.

• Effective communication and stakeholder management abilities.

• Proficiency in ETQ and electronic quality management systems.

• Strong report writing and presentation skills.

• Project management and organizational skills.

• Ability to influence and drive cross-functional compliance and continuous improvement initiatives.

Key Performance Indicators (KPIs)

• Successful maintenance of all management system certifications.

• Zero major non-conformities during external audits.

• 100% completion of annual internal audit programme.

• ≥95% on-time closure of CAPAs.

• ≥98% document review and control compliance.

• ≥95% training compliance rate.

• Effective ETQ system utilization and workflow compliance.

• Timely completion of management reviews.

• Continuous improvement project implementation and effectiveness.

• Achievement of Quality Objectives and Management System targets.