Quality Management System (QMS) Specialist

OPTICSX SDN. BHD.; Shah Alam; On-site; MYR 90,000 - 140,000; Full time

Job summary

OPTICSX SDN. BHD. seeks a Quality Management System (QMS) Specialist to develop, maintain, and improve the company's QMS, ensuring compliance with ISO and customer requirements in precision optical manufacturing.

You will drive quality system effectiveness, manage documentation, and promote continuous improvement. In this cross-functional role, you will plan and execute internal audits, support supplier and regulatory audits, and lead CAPA initiatives.

Qualifications

• 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.

Responsibilities

• Maintain and 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

Skills

ISO 9001

CAPA

Root cause analysis

Document control

Internal audits

Quality software

MS Office

Communication skills

Lean Six Sigma

Optics knowledge

Tools

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