Quality Engineer - #1118245

• 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.