全职 QA Executive 工作, 薪水 up to MYR 4,000, Ccb Medical Devices Pulau Pinang 公司招聘中 - Ricebowl

Key Responsibilities

• 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.

Pay: From RM4,000.00 per month

Benefits:

• Free parking
• Maternity leave

Work Location: In person