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A leading medical device manufacturer in Penang is seeking an Executive/Sr. Executive - Production (CNC) to direct manufacturing operations. The role requires a Diploma or Degree in Mechanical Engineering with 5–7 years' experience in CNC machining and expertise in ISO 13485 and FDA standards. Key responsibilities include managing operators and ensuring production meets volume and quality goals. Candidates should possess strong communication and problem-solving skills, with knowledge of CAD/CAM software being advantageous.
Responsible for directing the manufacturing operations performed in a shift or group of production lines, ensuring they reach volume, quality and cost goals.
Determine manufacturing processes and calculate machine and operator loads.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
Diploma or Degree in Mechanical Engineering, Manufacturing Technology, Mechatronics, or a related field.
Minimum 5–7 years of hands‑on experience in CNC machining, with at least 3‑5 years in 5‑axis milling.
Understanding of ISO 13485, FDA, and GMP standards and experience with quality control tools (e.g., 8D, CAPA, SPC) and audit readiness.
Strong communication and problem‑solving skills to manage cross‑functional collaboration. Positively influence the team members to strive for excellence.
Knowledge of Industry 4.0 technologies like machine monitoring, data analytics, and automation.
Familiarity with CAD/CAM software.
Experience in medical device manufacturing is a major advantage due to regulatory complexity.
Proven experience working in a people‑centric production setting, with a strong focus on teamwork, communication, discipline, and employee engagement.
Strong capability in managing a large headcount of operators and technicians, including manpower planning, shift arrangement, performance monitoring, and discipline control.
Well‑versed in Microsoft Applications (Word, Excel, PowerPoint, Power BI).
Problem Solving from theory to practice and implementation.
Understanding production demand and meeting customer requirements.