Engineer

2 weeks ago

Pasir Ris, Singapore Fong’s Engineering & Manufacturing Pte Ltd Full time

**Engineer, Quality**

Job Descriptions
- Create quality inspection plans and work instructions for incoming, In-process or outgoing parts

to ensure that components and products conform to specifications.
- Define training plan, train QC supervisors, QC technicians and QC inspectors to perform

dimensional/functional inspection in accordance to work instructions.
- Perform First Article Inspection for newly inducted materials and parts.
- Perform qualification validation of equipment, processes and test methods.
- Ensure the compliance of equipment and tools use during inspection in accordance to

Calibration and Preventive Maintenance requirements.
- Participate in Process Failure Mode Effect and Analysis team to mitigate product risk arising

from manufacturing.
- Perform complaint handling, investigate root cause of complaint and perform Corrective Action

and Preventive Action as necessary.
- Handle non-conformances and perform disposition of rejected parts, trend yield and rejects,

investigate root cause of non-conformance and perform Corrective Action and Preventive Action

as necessary.
- Maintain the manufacturing environment and perform gowning as necessary when working in

controlled manufacturing environment e.g. clean room.
- Initiate and/or execute engineering changes in compliance with Engineering Change Control

procedures.
- Participate in external and internal audit to ensure company quality system is effective.
- Participate in continuous improvement programs such as 6S program, yield improvement

projects etc.
- Support new production introduction as a team member representing quality.
- Perform other tasks as assigned by the supervisor.

Requirement:

- Bachelors Degree in Engineering, Science or equivalent.

**Experience**:

- Work experience as a quality engineer in a medical device manufacturing environment

Quality Engineer position
- Experience with qualification validation of equipment, processes and test methods for new

product introduction**

Skills:

- ISO13485 Internal auditor
- Statistical Analysis (Hypothesis Ttesting ANOVA, Gage R&R, DOE etc.)
- Root cause analysis (Kepner-Tregoe, 5-Why, 6M etc.)
- Risk Analysis (PFMEA)**

If you are looking for challenges and have the qualities and experience to undertake this challenging

experience, present and expected salary, and notice period.

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