QMS Engineer: Lead ISO 9001 Compliance & Improvement

Career Wise; Seberang Perai; On-site; MYR 67,000 - 134,000; Full time

Job summary

Career Wise in Penang, Malaysia seeks a Quality Assurance/QMS Specialist to maintain and improve the QMS, ensure ISO 9001 compliance, and manage controlled documents. You will coordinate audits, track CAPA actions, and drive cross-functional improvements with Production, Engineering, and NPI teams.

The role requires 1–2 years in QMS or manufacturing quality, strong documentation, analytical and communication skills, and familiarity with CAPA, FMEA, SPC, and risk management.

Qualifications

• Bachelor's degree in Quality, Engineering, Manufacturing, or related discipline.
• 1-2 years of experience in QMS, QA, or manufacturing quality.
• Strong working knowledge of ISO 9001.
• Experience in internal and external audit coordination.
• Familiar with CAPA, 8D, RCA, FMEA, SPC, MSA, and risk management.

Responsibilities

• Maintain and improve the company's Quality Management System (QMS).
• Ensure ISO 9001 requirements and internal quality procedures are met.
• Prepare, review, and control SOPs, Work Instructions, and other documents.
• Coordinate internal, customer, and certification audits.
• Follow up on audit findings and implement CAPA actions.
• Monitor QMS performance and prepare quality reports and KPI analyses.
• Lead or support RCA, 8D, 5 Why, Fishbone, and corrective actions.
• Manage document control and revised procedures implementation.
• Support CSR compliance across departments.
• Coordinate Management Review inputs and reports.
• Monitor quality objectives, KPIs, risk management, and improvements.
• Support FMEA, Control Plan, SPC, MSA, and process improvements.
• Conduct QMS awareness and quality training for employees.
• Collaborate with Production, Engineering, NPI, and Operations to fix systemic issues.
• Drive continuous improvement to strengthen the overall quality system.

Skills

Quality management

Audit coordination

Documentation

Analytical thinking

Problem-solving

Communication

Cross-functional teamwork

Education

Bachelor's degree in Quality/Engineering/Manufacturing

ISO 9001 knowledge

Tools

CAPA

FMEA

SPC

MSA

8D

Job description

Career Wise in Penang, Malaysia seeks a Quality Assurance/QMS Specialist to maintain and improve the QMS, ensure ISO 9001 compliance, and manage controlled documents. You will coordinate audits, track CAPA actions, and drive cross-functional improvements with Production, Engineering, and NPI teams.

The role requires 1–2 years in QMS or manufacturing quality, strong documentation, analytical and communication skills, and familiarity with CAPA, FMEA, SPC, and risk management.