QUALITY MANAGER

SUN ROUND TECHNOLOGY (MALAYSIA) SDN BHD; Seberang Perai; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading technology firm in Penang, Malaysia is seeking an experienced Quality Manager to oversee the Quality Management System (QMS) and mentor quality team members. You will ensure compliance with ISO standards, manage customer complaints, and drive continuous improvement initiatives. The ideal candidate possesses a Bachelor's degree and at least 7 years of experience in quality management, particularly within the medical industry. Strong leadership and analytical skills are essential for success in this role.

Qualifications

• Minimum 7 years in quality management, particularly in the medical/regulated industry.
• Over 7 years of ISO audit experience.
• Strong knowledge of ISO 9001 and ISO 13485 standards.

Responsibilities

• Oversee the Quality Department and the QMS.
• Monitor production processes for quality standards.
• Plan and lead ISO audits and manage QMS documentation.
• Conduct risk assessments and lead quality improvement initiatives.
• Analyze quality data for trends and opportunities.

Skills

Leadership

Analytical skills

Problem-solving

Communication skills

Education

Bachelor's degree in manufacturing/medical/science or related field

Job description

Oversee the Quality Department to ensure the effectiveness of the Quality Management System (QMS).

Mentor, engage, and provide guidance to quality team members.

Support other management functions related to quality and compliance initiatives.

Quality Control & Product Conformance

Monitor production processes to uphold high-quality standards.

Halt non-conforming materials, work-in-progress, or finished goods as necessary.

Liaise with the Production team to resolve issues and prevent recurrence.

ISO & QMS Management

Maintain and improve the QMS in compliance with ISO 13485:2016, ISO 9001:2015, and ISO 14971.

Plan and lead ISO audits, ensuring timely resolution of findings.

Ensure all quality documentation, SOPs, and records remain current and compliant.

Risk Management & Continuous Improvement

Conduct risk assessments and implement mitigation strategies.

Lead Lean, Kaizen, and Six Sigma initiatives to enhance processes.

Foster a culture of quality awareness and risk-based thinking.

Measurement & Analysis

Oversee SPC, MSA, and test method validation for accuracy and compliance.

Maintain calibration and inspection of all measurement equipment.

Analyze quality data to identify trends and improvement opportunities.

Customer & Communication Responsibilities

Manage responses to customer complaints and Corrective Action Requests (CARs).

Communicate quality performance and improvement plans to management.

Collaborate with cross-functional teams to ensure customer satisfaction.

Job Requirements

Bachelor's degree in manufacturing/medical/science, or related field.

Minimum 7 years in quality management and over 7 years of ISO audit experience; medical/regulated industry experience preferred.

Strong leadership, analytical, problem-solving, and communication skills.

Knowledge of ISO 9001 and ISO 13485 standards.