JOB SUMMARY:
Applies advanced and specialized skills, typically acquired through a combination of job-related vocational training and considerable relevant work experience. May require external certification in some disciplines. Supports the delivery of new solutions to complex problems where precedent may not exist. Perform a variety of the most complex tasks. Adapt procedures, techniques, tools, material, and/ or equipment to resolve complex issues. Work autonomously with little supervision required. Coordinating the work of others performing a variety of tasks that could be a routine or non-routine in nature but is not a supervisor.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Include the following. Other duties may be assigned.
- Involve and support Health and Safety programs (DWB, BBS, H&S meetings).
- Responsible for the safe operations of equipment to manufacture products. Perform checks and ensure safety features (machine guarding, interlocks, etc) is in place and under any circumstances should not bypass.
- Report immediately to direct supervisor if any safety features (machine guarding, interlocks, etc) are not functional or present some alteration.
- Ensure cleanliness of working place by performing line clearance following MPI0004
- Perform assigned assembly process in accordance with the Line Clearance Procedure (MPI0004), Manufacturing Process Instruction (MPI) and Lot History Record (LHR).
- Ensure product labelling, identification and traceability based on MPI0006
- Ensure nonconforming products are properly labelled on MPI and QI assigned on the process.
- Ensure the accuracy of material inventory/usage in production
- Involve and support in Production/ Engineering improvement project (Kaizen).
- Plan and ensure that the production target is met (Productivity and Shipment). Must know how to calculate HC, Overtime, and output requirement
- Ensure the effectiveness of Awareness and Competency Training in the line
- Work with Production Training Coordinator to ensure the completeness and accuracy of Training Records
- Maintain and comply with ISO13485, GMP and FDA regulations
Education/Experience and Qualifications
GCE “O” level or higher with 6+ years assembly experience preferably in medical device.
Work Environment
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
Controlled Environment (Class 100K cleanroom) and office area.
