Quality Assurance engineer

Job purpose

• Lead new product/process validation, including DQ, IQ, OQ and PQ stages.
• Revalidation for validated product or process every 5 years.
• Yearly baseline checking for validated product/process.
• Product compliance with customer’s drawing and quality agreement.
• Responsible for handling customer complaint.
• Follow up corrective and preventive actions for customer complaint and internal deviation.
• Confirm defective parts and review & close internal deviation report.
• New project introduction.
• Set up test plan for new product in Q-DAS system.
• Review test protocol and test report issued by production or technical team.

Areas of responsibility

Product/process validation:

• Lead new product/process validation, including DQ, IQ, OQ and PQ stages.
• Revalidation for validated product or process every 5 years (Pin for base/EMGO Peek/AI machine/ST line1 and line 2/Waste-water treatment machine).
• Lead a cross-function team to finish control plan, FMEA, MA and test plan for new product/process.
• Yearly baseline checking for validated product/process (Pin for base/EMGO Peek/AI machine/ST line1 and line 2/Waste-water treatment machine).

Customer complaint (Pin for base/EMGO Peek/AI machine/ST line1 and line 2/Waste-water treatment machine):

• As a contact window of customer complaint and forward related information to internal team.
• Handling customer complaints, including root cause analyses and implementation of corrective actions and preventive actions
• Finish customer complaint report.

Continuous improvement activities (Pin for base/EMGO Peek/AI machine/ST line1 and line 2/Waste-water treatment machine):

• Review internal deviation reports issued by production team or technical team and give comments.
• Send internal deviation report to customer if need and close it.
• Follow up corrective and preventive actions for internal deviation.
• Approve new WI or updated WI issued by production team or technical team.
• Review test protocol and test report for process improvement.
• Review and close CAPA project if need.

Daily work (Pin for base/EMGO Peek/AI machine/ST line1 and line 2/Waste-water treatment machine):

• Approve Opr.05 for new route card from production.
• Defective parts judgment and sign the limit sample for internal team.
• Uniform inspection method between production and QC team.
• Participate internal audit, customer audit and 3rd party audit, and follow up corrective and preventive actions if need.
• ST department partner and coordinator for internal deviation.
• Other work assigned by QA manager.

Qualification

• Good English skills in both writing and oral
• Skills in “Good documentation practice”.
• Internal audit experience.
• Have worked with ISO13485, minimum ISO9001 or TS16949.
• Have problem solving skills as “8D”, "5 Why","DMAIC" or similar.
• Knowledge about "control plan","FMEA","MSA" etc.
• Have worked with "change control", "CAPA" or "validation".