QMS Engineer

Key Responsibilities

• Maintain and control QMS/EMS documentation in compliance with ISO 13485, ISO 9001 and ISO 14001.
• Plan, schedule and conduct internal audits and support customer, regulatory and certification audits.
• Act as CAPA Coordinator, managing investigations, root cause analysis, corrective actions and closure.
• Prepare reports, data and minutes for Management Review and monitor QMS/EMS KPIs.
• Support supplier quality, supplier scorecards and corrective actions.
• Conduct training and awareness sessions on QMS, EMS and Good Documentation Practice (GDP).
• Participate in continuous improvement, sustainability and problem-solving projects.
• Support risk management and process validation activities where required.
• Ensure compliance with company Health, Safety, Quality and Environmental policies.

Requirements

• Minimum Diploma in Quality Management, Engineering, Environmental Science, Life Sciences or related field.
• 1–3 years of experience in QMS/EMS and CAPA.
• Experience in manufacturing or medical device industry is preferred.
• Strong knowledge of ISO 13485 / ISO 9001 / ISO 14001.
• Knowledge of CAPA, Root Cause Analysis, 5 Why, Fishbone and 8D.
• Good understanding of document control and audit processes.
• Knowledge of FDA 21 CFR Part 820, EU MDA or Malaysia MDA is an advantage.
• Experience in supplier quality and audit management is an added advantage.
• Good communication skills in English and Malay.
• Proficient in Microsoft Word, Excel and PowerPoint.
• Able to work independently, manage multiple priorities and work collaboratively.