QA Executive

CCB Medical Devices; Seberang Perai; On-site; MYR 60,000 - 110,000; Full time

Job summary

CCB Medical Devices in Penang seeks an experienced Quality Assurance/Quality Control professional to develop, implement, and maintain the QMS in line with ISO 13485 and FDA QSR requirements. You will perform inspections, document control, and support audits.

The role involves root cause analysis for customer complaints, CAPA and NCR management, supplier quality, and cross‑functional improvement with Production, Engineering, R&D, and Supply Chain to ensure regulatory compliance and product

Qualifications

• Bachelor’s degree in Engineering, Quality Management, Manufacturing or related field.
• 3+ years in Quality Assurance/Quality Control, preferably in medical devices.
• Knowledge of QMS, ISO 13485, CAPA, NCR management and risk tools.
• Experience in audits, complaint handling, and quality investigations.
• Familiarity with SPC, FMEA, and continuous improvement approaches.

Responsibilities

• Develop, implement, and maintain the QMS in compliance with ISO 13485 and FDA QSR.
• Perform quality inspections, product testing, and verification activities.
• Manage NCRs, CAPAs, change controls, and quality reports.
• Investigate customer complaints and perform root cause analysis.
• Collaborate with Production, Engineering, R&D, and Supply Chain to resolve issues.
• Conduct internal quality audits and support supplier quality assessments.
• Monitor quality performance data and recommend corrective actions.
• Support product/process validation and continuous improvement projects.
• Prepare documentation for customer audits and regulatory inspections.

Skills

Analytical thinking

Problem solving

Decision making

Communication

Attention to detail

Education

Bachelor’s Degree in Engineering

Tools

Microsoft Office

Job description

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• Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR requirements, and applicable medical device regulations.


• Perform quality inspections, product testing, and verification activities to ensure products meet customer specifications and regulatory requirements.


• Manage quality documentation and records, including Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), change controls, and quality reports.


• Investigate customer complaints, perform root cause analysis, and implement effective corrective and preventive actions.


• Collaborate with cross-functional teams, including Production, Engineering, R&D, and Supply Chain, to resolve quality issues and drive continuous improvement.


• Conduct internal quality audits and support supplier quality assessments to ensure compliance with quality standards.


• Monitor and analyze quality performance data, identify improvement opportunities, and recommend corrective actions.


• Support product/process validation activities and continuous improvement projects.


• Ensure compliance with product specifications, inspection procedures, and quality standards.


• Support customer audits and regulatory inspections by preparing required documentation and providing quality-related information.


• Perform other quality-related duties and special assignments as assigned by management.

Requirements

• Bachelor’s Degree in Engineering, Quality Management, Manufacturing, Industrial Technology, Science, or related disciplines.


• Minimum 3 years of experience in Quality Assurance/Quality Control, preferably in the medical device or regulated manufacturing industry.


• Knowledge and hands-on experience in Quality Management System (QMS), ISO 13485, CAPA, NCR management, risk management, and quality improvement tools.


• Experience in quality inspection, product testing, precision measurement equipment, and quality control methodologies.


• Experience in customer complaint handling, audit preparation, and quality investigation activities.


• Knowledge of SPC, MSA, FMEA, and continuous improvement methodologies will be an added advantage.


• Strong analytical, problem-solving, and decision-making skills.


• Good documentation, reporting, and record management skills.


• Good command of English and Bahasa Malaysia, both written and spoken.


• Proficient in Microsoft Office applications (Excel, Word, PowerPoint).


• Strong communication, coordination, and interpersonal skills.


• Able to manage multiple priorities and work independently in a fast-paced environment.


• Detail-oriented, proactive, adaptable, and willing to learn.