Karen Phoon

Experience

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  Straits Orthopaedics (Mfg) Sdn Bhd

  Jan 2007 - Aug 2010

  Engineering, System Administration

  1. Involved in New project transfer from Engineering to Production.2. Issued Engineering Job Route and related documents for Engineering.3. Implement the related documents for Engineering, Engineering Change and maintain records of Project transfer, such as Project launching, Contract review and etc.4. In charged of Project management, Tooling control and cost saving.5. Involved in ISO 13485, FDA audit. (Implant Medical Device)

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  Teleflex Incorporated

  Apr 2012 - Sept 2014

  QA Compliance Specialist

  1. Support the company QMS and involved in internal audit, external, corporate and 3rd party audit. Responsible follow up actions after audits.2. Performed internal audit and quality process audit.3. Implement document control system to compliance with ISO 13485, FDA 21 CFR 820, MDD and Medical Device Regulation in Canada SOR /98-282.4. Responsible in procedure / work instruction writing.5. Responsible / coordinate to ensure the Change Control management is implemented accordingly.6. Implement and maintain records of nonconforming product system, data analysis for NC, monthly trend for NC.7. Implement an effectiveness CAPA system. Assist CAPA project leader to compile data and CAPA project file. Reviewed CAPA file before CAPA closed.8. Assist in all regulatory activities and ensure QMS, 21 CFR Part 820, JPAL and SOR /98-282 are compliance.9. Maintain compliance with all ISO standard and procedure.10. Responsible for customer complaint communication and effective coordinate. Leads customer complaint database such as overseeing the root cause investigation, timely accomplishments of dispositions.11. Involved and implemented QMS documents for product transfer / new product. (Drawings, specification and etc).12. Compile data and prepare report for Management Review.13. Conduct product training and quality training when required. Show less

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  ABio Orthopaedics (Mfg) Sdn Bhd

  Sept 2014 - Sept 2018

  Senior Quality Engineer

  Responsibility of customer complaint issue, arrange of return products from customer, product replacement. Response to customer on quality issue and compile the action reports for customer.Final Quality Release for dimensional and visual checking. (Profile projector, thread ring gauge and so forth).Involved in quality internal audit, prepare audit checklist, conducting audit and compile audit report. Involved in KGMP audit, KFD, JQMS audit and others regulatory audit / inspection.Responsibility of review and approve of shipping documents prior product deliver to customer.Responsibility of review and approve of device history records. Confirm all records are available and good document practice for the records.Responsibility of customer audit on the quality department.Responsible of FDA registration shipment to US.Responsible of customer complaints, response to customer, disposition of the rejected parts, deal with finance to issue Credit notes and ensure complaints are closed properly.Responsible of CAPA process, involving investigations process, monitoring the effectiveness of the CAPA based on spot check, trend, audit and so forth.Responsible on monthly performance reviews data analysis, compiles all data into proper graph / trend. List actions for improvement and follow up.Conduct training for new comer. Show less

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  Straits Orthopaedics (Mfg) Sdn Bhd

  Sept 2014 - now

  Assistant Quality Assurance Manager