Senior Quality Assurance Lead — CAPA & Audits

Agensi Pekerjaan Career Wise Sdn Bhd; Kuala Ketil; On-site; MYR 120,000 - 180,000; Full time

Job summary

Agensi Pekerjaan Career Wise Sdn Bhd invites applications for a Quality Assurance/Quality Control leadership role in a manufacturing environment. You will supervise QA/QC teams, develop and maintain quality procedures, and ensure compliance with customer, regulatory and internal standards.

The role emphasizes CAPA investigation, audits, data analysis and cross-department collaboration to drive continuous improvement and product quality across the organization.

Qualifications

• 5+ years of quality-related experience in a manufacturing environment.
• Experience in the medical device or healthcare manufacturing industry is an added advantage.
• Supervisory or team-management experience is preferred.
• Familiarity with ISO 9001; knowledge of ISO 13485 or relevant medical-device regulations is advantageous.
• Experience handling internal, supplier, customer or regulatory audits.
• Able to use quality tools such as 8D, 5 Why, Fishbone Analysis, SPC and FMEA.
• Good command of Mandarin and Bahasa Malaysia to communicate with relevant employees and stakeholders.

Responsibilities

• Assist the Quality Manager in overseeing the quality management system and daily quality-control activities.
• Lead and supervise the QA and QC teams to ensure products meet requirements.
• Develop, implement and maintain quality procedures, work instructions and inspection standards.
• Monitor incoming materials, production processes and finished products for quality conformance.
• Investigate customer complaints, defects and non-conformance issues.
• Lead root-cause analysis and implement CAPA actions.
• Coordinate internal, customer, supplier and regulatory audits.
• Monitor supplier quality performance and collaborate with suppliers to resolve issues.
• Analyse quality data and prepare reports on defect rates and improvement actions.
• Work with Production, Engineering, Procurement and other departments to improve quality.
• Conduct quality training and promote continuous improvement throughout the organization.
• Ensure quality records and documentation are properly maintained and controlled.
• Support compliance with relevant quality standards and regulatory requirements.
• Perform other quality-related duties assigned by management.

Skills

Quality Leadership

Analytical thinking

Communication

Problem-solving

Cross-functional collaboration

Documentation

Education

Diploma or Bachelor's Degree in Quality Management, Engineering, Manufacturing

Tools

8D

5 Why

Fishbone Analysis

SPC

FMEA

Job description

Agensi Pekerjaan Career Wise Sdn Bhd invites applications for a Quality Assurance/Quality Control leadership role in a manufacturing environment. You will supervise QA/QC teams, develop and maintain quality procedures, and ensure compliance with customer, regulatory and internal standards.

The role emphasizes CAPA investigation, audits, data analysis and cross-department collaboration to drive continuous improvement and product quality across the organization.