Job Scope:
- Assist Supervisor / Line Leader in daily line operations.
- Lead a group of 10 to 15 Operators to achieve the production goals and objectives.
- To arrange and/or assign the operators daily activities, ensuring that the operators are properly trained and competent in the assignment. Make the necessary arrangement for the operators to be trained.
- Update the training matrix and ensure the operators training matches the current training revision.
- To arrange and perform daily and/or monthly inventory or cycle count.
- Submit reports that are related to the daily activities.
- Ensure assembly and testing activities are done in accordance with established work standards, cGMP, safety, Test and assembly procedures, and work schedule.
- Assist Technicians and/or Engineers in the 1st level analyzes of defective materials to determine the cause of failure and production yield issues.
- Work with supervisor and assist engineers to execute controlled experiments/ evaluation run to address equipment-related yield and quality issues and drive implementation of solutions in a production environment to meet production goals.
- Support process improvement activities to meet production goals.
- Perform any other similar and or related duties as may be directed by the Production Supervisor.
- Ensure Daily 5S and Lean objectives are met.
- To operate basic software operating system
- Ensure compliance with all existing Quality management systems, company policies, ISO 9k/13485, cGMP, MDSAP, safety policy, legal requirements, etc.
Requirement:
- Diploma in Electrical, Mechanical or Mechatronics Engineering, with minimum 3 years of experience in a regulated manufacturing environment, or
- NTC or ITE Certificate in Mechanical, Electrical or Mechatronics Engineering with 5 years of experience in a regulated manufacturing environment.
- Minimum 2 years working experience working in a quality management system in compliance with ISO 13485-2016 or CFR 21 or cGMP production floor.
- Ability to read and understand technical drawings, specification and data sheets.
- Participated in ISO 13485-2016 audit or FDA inspection would be an advantage
How to Apply
If you are interested in exploring this roleor other current openings in the market, kindly email me [Confidential Information] with your resume.
We regret to inorm that only shortlistefdcandidates will be notified.
Ashley Loo Yan Ni | R2095115 | EA LicenseNumber: 99C4599
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