QMS Engineer

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

Job Summary:

The successful candidate will work closely with Quality, Production, Engineering, NPI, and other departments to maintain an effective QMS and drive continuous improvement.

Key Responsibilities:

• Maintain and continuously improve the company's Quality Management System (QMS).
• Ensure compliance with ISO 9001 requirements and internal quality procedures.
• Prepare, review, and control SOPs, Work Instructions, Quality Procedures, Forms, and other controlled documents.
• Coordinate and support internal, customer, and certification audits.
• Follow up on audit findings and ensure timely implementation of Corrective and Preventive Actions (CAPA).
• Monitor QMS performance and prepare quality reports and KPI analysis.
• Lead or support RCA, 8D, 5 Why, Fishbone, and corrective action activities.
• Manage document control and ensure effective implementation of revised procedures and requirements.
• Support customer-specific requirements (CSR) and ensure compliance across relevant departments.
• Coordinate Management Review activities and prepare required inputs and reports.
• Monitor and follow up on quality objectives, KPIs, risk management, and improvement actions.
• Support FMEA, Control Plan, SPC, MSA, and process improvement activities.
• Conduct QMS awareness and quality-related training for employees.
• Work closely with Production, Engineering, NPI, and Operations teams to identify and eliminate systemic quality issues.
• Drive continuous improvement initiatives to strengthen the overall quality system.

Requirements:

• Bachelor's Degree in Quality, Engineering, Manufacturing, or related discipline.
• 1-2 years of experience in QMS, Quality Assurance, or manufacturing quality.
• Strong working knowledge of ISO 9001.
• Experience in internal and external audit coordination.
• Good understanding of CAPA, 8D, RCA, FMEA, SPC, MSA, and risk management.
• Experience in electronics, EMS, PCBA, SMT, or manufacturing is highly preferred.
• Familiarity with IPC-A-610 and customer‑specific requirements is an advantage.
• Strong documentation, analytical, problem-solving, and communication skills.
• Able to work independently and effectively with cross‑functional teams.
• ISO 9001 Internal Auditor / Lead Auditor certification is an advantage.