Duty and responsibility
Plan, organize and ensure the First Article, Incoming QC, In-Process QC; Final-QC activities are performed efficiently and.....
Duty and responsibility
Plan, organize and ensure the First Article, Incoming QC, In-Process QC; Final-QC activities are performed efficiently and effectively.
Supervise and lead a team of QC Leaders/Specialist/Inspectors.
Establish, review quality control plans, standard operating procedures to ensure products and processes conform with customer specifications
Work with cross functional departments to ensure product quality and system requirements are realized.
Liaise with suppliers to improve their processes and resolve material/component related quality issues including RTV lots.
Perform internal audit to warrant processes and procedures are well maintain and comply with ISO 9001, 13485 Standards and Regulatory requirements
Lead in the investigation of product non-conformity, gather, analyse data to determine root cause and implement corrective/preventive action to prevent recurrence.
Requirement
5 years’ experience in QA functions, preferably in the medical device/plastic moulding manufacturing.
Good knowledgeable in statistical techniques, eg SPC, CPK, Gage R&R and FMEA.
Well versed in measurement metrology eg, familiar with CMM, Smart-scope and the ability to interpret Engineering drawings and specifications.
Computer literate with proficiency in Microsoft Office (Word, Excel, and Power Point).
