QA Assistant Manager

Richter Rubber Technology; Baling; On-site; MYR 120,000 - 180,000; Full time

Job summary

Jora Malaysia is seeking a QA professional to assist the QA Manager in maintaining and improving the Quality Management System (QMS) in line with ISO 13485 and applicable regulatory requirements. The role focuses on ensuring compliance with medical device standards, monitoring quality performance, and supporting regulatory audits.

The incumbent will coordinate quality system processes, lead root cause investigations, support regulatory submissions, and drive continuous improvement across

Qualifications

• Degree/Diploma in Quality Management, Engineering, Science, Manufacturing or related field.

Responsibilities

• Assist the QA Manager in maintaining and improving the Quality Management System (QMS) in accordance with ISO 13485 and applicable regulatory requirements.
• Ensure compliance with applicable medical device standards, regulatory requirements and company procedures.
• Monitor product quality, production processes and quality performance.
• Conduct and support internal, external and regulatory audits.
• Coordinate and maintain quality system processes, including document control, change control, deviation management, nonconformance management, CAPA, risk management, and complaint handling.
• Review and maintain quality documentation, specifications, procedures and records.
• Lead root cause investigations and coordinate the implementation and verification of corrective and preventive actions.
• Support product registration, regulatory submissions, and post-market surveillance activities.
• Review packaging artwork, labeling, instructions for use, declarations, certificates, and other regulatory documents to ensure compliance with applicable market requirements.
• Coordinate validation activities, including process validation, cleaning validation, method validation, software validation, and other validation projects.
• Work closely with Production, Supply Chain, Maintenance and other departments to resolve quality issues.
• Monitor product quality trends, customer complaints, production performance, and quality indicators, and recommend improvement actions.
• Prepare quality reports and present findings, trends, and improvement activities during operational and management review meetings.
• Lead continuous improvement projects to enhance product quality, process effectiveness, and regulatory compliance.

Skills

Analytical skills

Problem solving

Communication

Education

Bachelor's/Diploma in Quality Management

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

Assist the QA Manager in maintaining and improving the Quality Management System (QMS) in accordance with ISO 13485 and applicable regulatory requirements.

Ensure compliance with applicable medical device standards, regulatory requirements and company procedures.

Monitor product quality, production processes and quality performance.

Conduct and support internal, external and regulatory audits.

Coordinate and maintain quality system processes, including document control, change control, deviation management, nonconformance management, CAPA, risk management, and complaint handling.

Review and maintain quality documentation, specifications, procedures and records.

Lead root cause investigations and coordinate the implementation and verification of corrective and preventive actions.

Support product registration, regulatory submissions, and post-market surveillance activities.

Review packaging artwork, labeling, instructions for use, declarations, certificates, and other regulatory documents to ensure compliance with applicable market requirements.

Coordinate validation activities, including process validation, cleaning validation, method validation, software validation, and other validation projects.

Work closely with Production, Supply Chain, Maintenance and other departments to resolve quality issues.

Monitor product quality trends, customer complaints, production performance, and quality indicators, and recommend improvement actions.

Prepare quality reports and present findings, trends, and improvement activities during operational and management review meetings.

Lead continuous improvement projects to enhance product quality, process effectiveness, and regulatory compliance.

Job Responsibilities

• Assist the QA Manager in maintaining and improving the Quality Management System (QMS) in accordance with ISO 13485 and applicable regulatory requirements.
• Ensure compliance with applicable medical device standards, regulatory requirements and company procedures.
• Monitor product quality, production processes and quality performance.
• Conduct and support internal, external and regulatory audits.
• Coordinate and maintain quality system processes, including document control, change control, deviation management, nonconformance management, CAPA, risk management, and complaint handling.
• Review and maintain quality documentation, specifications, procedures and records.
• Lead root cause investigations and coordinate the implementation and verification of corrective and preventive actions.
• Support product registration, regulatory submissions, and post-market surveillance activities.
• Review packaging artwork, labeling, instructions for use, declarations, certificates, and other regulatory documents to ensure compliance with applicable market requirements.
• Coordinate validation activities, including process validation, cleaning validation, method validation, software validation, and other validation projects.
• Work closely with Production, Supply Chain, Maintenance and other departments to resolve quality issues.
• Monitor product quality trends, customer complaints, production performance, and quality indicators, and recommend improvement actions.
• Prepare quality reports and present findings, trends, and improvement activities during operational and management review meetings.
• Lead continuous improvement projects to enhance product quality, process effectiveness, and regulatory compliance.

Requirements

• Degree/Diploma in Quality Management, Engineering, Science, Manufacturing or related field.
• Minimum 10 within the medical device industry. Experience in rubber, latex, or condom manufacturing and pharmaceutical field will be an added advantage.
• Strong knowledge of medical device quality management systems and regulatory requirements.
• Strong analytical, problem-solving, and communication skills.
• Knowledge of the following standards is an advantage:
• ISO 13485 – Medical Device QMS
• ISO 14971 – Medical Device Risk Management
• ISO 10993 – Biological Evaluation of Medical Devices
• ISO 4074 – Natural Rubber Latex Male Condoms
• EU MDR 2017/745
• FDA 21 CFR