Quality Engineer
1 week ago
- 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.
Experience/ Skills
- Work experience as a quality inspector.
- Candidates with more work experience can be considered for senior position).
- Work experience in a medical device manufacturing environment
- Able to understand basic mechanical drawings and specification.
- Competent using handheld inspection tools such as calipers, micrometers, gages etc.
- Competent using inspection equipment such as optical comparator, microscopes etc.
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