Deskripsi Pekerjaan
Join D&K Engineering as a QMS Engineer/Executive!
Are you a meticulous and driven Quality Management System (QMS) professional with a passion for compliance and continuous improvement? D&K Engineering, a leader in advanced product development and manufacturing, is seeking a dedicated QMS Engineer/Executive to join our dynamic team in Ulu Tiram, Johor. This pivotal role is essential for upholding our commitment to world-class quality and environmental standards across our operations.
As a QMS Engineer/Executive, you will be instrumental in the establishment, maintenance, and enhancement of our integrated Quality and Environmental Management Systems (QMS/EMS), specifically focusing on ISO 13485, ISO 9001, and ISO 14001. You will serve as a key advocate for compliance, ensuring all processes meet stringent regulatory and internal requirements. A significant part of this role involves acting as the CAPA Coordinator, meticulously managing Corrective and Preventive Actions from identification through to effective resolution, thereby driving systemic improvements and mitigating risks.
This is an exceptional opportunity for an individual who thrives in a fast-paced manufacturing environment, possesses a keen eye for detail, and demonstrates strong analytical and problem-solving abilities. You will collaborate closely with various departments, influencing operational excellence and contributing directly to our product quality and environmental stewardship. If you are ready to make a tangible impact by ensuring adherence to global quality benchmarks and fostering a culture of continuous improvement, we invite you to explore this exciting career with D&K Engineering.
Tanggung Jawab
- Develop, implement, and maintain D&K Engineering's Quality Management System (QMS) in accordance with ISO 9001 and ISO 13485 standards.
- Manage and improve the Environmental Management System (EMS) to ensure compliance with ISO 14001 requirements.
- Serve as the CAPA Coordinator, overseeing the complete lifecycle of Corrective and Preventive Actions, including investigation, root cause analysis, implementation, and verification of effectiveness.
- Conduct internal audits and facilitate external audits to ensure ongoing compliance with QMS, EMS, and regulatory standards.
- Monitor and analyze quality performance data, identifying trends and opportunities for process improvement.
- Ensure effective control of non-conforming materials and products, coordinating disposition and necessary corrective actions.
- Provide training and guidance to staff on QMS/EMS procedures, quality tools, and compliance requirements.
- Prepare and present reports on QMS/EMS performance to management, recommending strategic improvements.
Kualifikasi
- Bachelor's degree in Engineering (e.g., Mechanical, Industrial, Quality), Science, or a related technical field.
- Minimum of 3-5 years of experience in Quality Management Systems within a manufacturing or engineering environment.
- Proven expertise in ISO 9001, ISO 13485 (medical devices), and ISO 14001 standards.
- Demonstrated experience as a CAPA Coordinator or in a similar role involving root cause analysis and problem-solving methodologies (e.g., 8D, FMEA).
- Strong understanding of quality tools and techniques (e.g., SPC, Lean, Six Sigma).
- Excellent analytical, organizational, and communication skills (written and verbal).
- Ability to work independently and collaboratively in a cross-functional team environment.
- Certified Internal Auditor for ISO standards is a distinct advantage.