QA Engineer

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).