- Ulu Tiram, Johor
- Analysis & Reporting (Manufacturing, Transport & Logistics)
- Full time
- Add expected salary to your profile for insights
POSITION SUMMARY:
Ensure that the Quality Management System (QMS) and Environmental Management System (EMS) are effectively implemented, maintained, and improved. Support Management Review, CAPA, internal audits, supplier quality, and compliance to ensure that the organization consistently meets regulatory requirements and customer expectations.
ESSENTIAL FUNCTIONS:
General and Task Management
- Maintain and control QMS/EMS documentation, ensuring compliance with ISO13485/ISO9001/ISO14001.
- Assist in planning, scheduling, and conducting internal audits; support external audits (customer, regulatory, certification body).
- Act as CAPA Coordinator: manage CAPA system, ensure timely investigations, root cause analysis, and closure.
- Prepare data, reports, and minutes for Management Review; monitor QMS/EMS KPIs (NCs, CAPA, audit findings).
- Support supplier quality and environmental compliance (documentation, scorecards, corrective actions).
- Assist in training and awareness sessions on QMS, EMS, and GDP (Good Documentation Practice).
- Support continuous improvement projects, sustainability initiatives, and problem-solving activities.
- Participate in risk management and process validation activities where required.
- Ensure compliance with company Health, Safety, and Environmental policies.
Self-Management
- Comply with Health, Safety, Quality, and Environmental Policies.
- Achievement-focused, with strong compliance mindset.
- Team player with a collaborative approach.
- Resilient, optimistic, and adaptable to change.
- Shows integrity, openness, and accountability in all tasks.
- Able to manage multiple priorities effectively.
Skills and Attributes:
- Strong understanding of Quality and Environmental Management Systems (ISO13485/ISO9001/ISO14001).
- Knowledge of CAPA, root cause analysis, and problem-solving tools (5 Why, Fishbone, 8D).
- Good documentation control and audit process knowledge.
- Ability to work in a diverse and dynamic environment.
- Analytical, planning, and prioritization skills.
- Good communication and interpersonal skills in English and Malay.
- Proficiency in MS Office (Word, Excel, PowerPoint).
- Ability to work independently and take initiative.
Qualifications and Experience Levels:
- Minimum Diploma in Quality Management, Engineering, Environmental Science, Life Sciences, or related field.
- 1–3 years of experience in QMS/EMS & CAPA (preferably in manufacturing or medical devices).
- Awareness of regulatory standards such as ISO13485, ISO9001, ISO14001, and Medical Regulatory (i.e., FDA 21 CFR Part 820, EU MDA, Malaysia MDA, etc.) is a plus point.
- Experience in supplier quality and audit management is advantageous.
- Commitment to professional development and continuous learning.
APPLY AT :- JOBSTREET MALAYSIA – D&K ENGINEERING SERVICES SDN BHD