Quality Management System (QMS) Specialist

Opticsx Sdn. Bhd.

Selangor

On-site

MYR 60,000 - 100,000

Full time

29 hours ago
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Job summary

Opticsx Sdn. Bhd. is seeking a Quality Management System (QMS) Specialist to develop, maintain, and improve the company’s QMS, ensuring compliance with ISO and industry requirements.

You will drive audit readiness, document control, CAPA, and cross-functional collaboration across Manufacturing, Engineering, Supply Chain, and Operations to sustain product quality and process consistency. The role emphasizes facilitating internal and external audits, leading continuous improvement initiatives with

Qualifications

  • 3+ years of experience supporting or administering a QMS in a manufacturing environment.
  • Proficiency with ISO 9001 requirements and auditing principles.
  • Experience with CAPA, nonconformance management, root cause analysis, and document control.
  • Strong analytical, problem-solving, and organizational skills.
  • Excellent written and verbal communication skills.

Responsibilities

  • Maintain and continuously improve the Quality Management System in accordance with ISO 9001 and other applicable standards.
  • Manage quality system documentation, including procedures, work instructions, forms, policies, and records.
  • Plan, schedule, and conduct internal quality audits.
  • Support customer, regulatory, and certification audits.
  • Administer CAPA processes across the organization and facilitate root cause investigations.
  • Ensure compliance with applicable regulatory, customer, and industry requirements.
  • Lead or participate in continuous improvement projects utilizing Lean Manufacturing and Six Sigma principles.
  • Conduct QMS-related training for employees and promote quality culture and awareness throughout the organization.
  • Support investigation and resolution of customer quality concerns.
  • Collaborate with suppliers and internal teams to improve quality performance.

Skills

Quality management experience
ISO 9001
CAPA
Root cause analysis
Documentation control
Analytical skills
Communication skills
Multi-project management
Quality tools
Domain: optics/photonics

Tools

Microsoft Office Suite
Quality management software

Job description

Quality Management System (QMS) Specialist

The Quality Management System (QMS) Specialist is responsible for developing, maintaining, and improving the company's Quality Management System to ensure compliance with applicable standards, customer requirements, and regulatory expectations. This role supports the manufacture of precision optical components, assemblies, and related products by driving quality system effectiveness, facilitating audits, managing quality documentation, and promoting continuous improvement initiatives throughout the organization. The QMS Specialist works cross-functionally with Manufacturing, Engineering, Supply Chain, Operations, and Customer Quality teams to ensure product quality, process consistency, and compliance with ISO and industry-specific requirements.

Key responsibilities
  • Maintain and continuously improve the Quality Management System in accordance with ISO 9001 and other applicable standards
  • Manage quality system documentation, including procedures, work instructions, forms, policies, and records
  • Plan, schedule, and conduct internal quality audits
  • Support customer, regulatory, and certification audits
  • Administer CAPA processes across the organization and facilitate root cause investigations using methodologies such as 5 Why, Fishbone, Pareto Analysis, and FMEA
  • Ensure compliance with applicable regulatory, customer, and industry requirements
  • Lead or participate in continuous improvement projects utilizing Lean Manufacturing and Six Sigma principles
  • Conduct QMS-related training for employees and promote quality culture and awareness throughout the organization
  • Support investigation and resolution of customer quality concerns
  • Collaborate with suppliers and internal teams to improve quality performance
About you
  • 3+ years of experience supporting or administering a Quality Management System in a manufacturing environment
  • Working knowledge of ISO 9001 requirements and auditing principles
  • Experience with CAPA, nonconformance management, root cause analysis, and document control
  • Strong analytical, problem-solving, and organizational skills
  • Proficiency with Microsoft Office Suite and quality management software systems
  • Excellent written and verbal communication skills
  • Experience within optics, photonics, aerospace, defense, medical device, or precision manufacturing industries
  • Thorough understanding of quality system requirements and quality tools
  • Ability to interpret technical drawings, specifications, and customer requirements
  • Ability to manage multiple projects and priorities simultaneously
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