JOB SUMMARY :
Applies job skills and company policies and procedures, typically acquired through a combination of limited prior relevant on-the-job or vocational training and/or relevant work experience and knowledge of company policies and procedures. May recognize need for deviation from established procedures where necessary. Duties and task are varied and semi-routine. Works under direct and general supervision. Normally receives general instruction on work.
ESSENTIAL DUTIES AND RESPONSIBILITIES : Include the following. Other duties may be assigned.
- Ensure cleanliness of working place by performing line clearance following MPI0004
- Trained and certified in at least 2 process operations.
- 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.
- Perform assigned assembly process in accordance with the Line Clearance Procedure (MPI0004), Manufacturing Process Instruction (MPI) and Lot History Record (LHR).
- Perform product labelling, identification and traceability based on MPI0006
- Identify any nonconforming products during the assembly base on MPI and QI assigned on the process.
- Ensure that the production target is met.
- Maintain and comply with ISO13485, GMP and FDA regulations
Education/Experience and Qualifications
GCE “O” level or higher with 1+ 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.
