· 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
· Work experience as a quality engineer in a medical device manufacturing environment
(Candidates with Diploma in Engineering. Science or equivalent can be considered for Assistant Quality Engineer position. Candidates with more experience can be considered for Senior Quality Engineer position)
· Experience with qualification validation of equipment, processes and test methods for new product introduction
