Andrea Chen Email & Phone Number

Taoyuan City, Taiwan

Medical Device Regulatory Consultant

Hsinchu City, Taiwan, Taiwan

Skyla Corporation Hsinchu Science Park Branch ·

Tucheng District, New Taipei City, Taiwan

Implement ISO 13485, ISO 14971 and ISO 62304 regulation related training for different teams.Collaborator with software teams to complete the software validation report for FDA EUA documentation preparation.Assist in the introduction of quality system in accordance with GMP, ISO 13485 and FDA 21 CFR 820.CLIA WAIVE analysis, application and internal presentation

New Taipei City, Taiwan

•Supervise of customer complain handling, RMA processing, and quality system regulations.•Execute internal and external quality audits, include internal audits, supplier audits, notify body audits, customer audits, FDA and TFDA audits.•Maintain quality system (GMP, ISO 13485, MDSAP) and Medical Device Certificates of TFDA, U.S. FDA and CE.•Monitoring monthly calibration plan and reports.•Monthly Quality Meeting, monitoring of domestic and international RMA, CAPAs, customer… Show more •Supervise of customer complain handling, RMA processing, and quality system regulations.•Execute internal and external quality audits, include internal audits, supplier audits, notify body audits, customer audits, FDA and TFDA audits.•Maintain quality system (GMP, ISO 13485, MDSAP) and Medical Device Certificates of TFDA, U.S. FDA and CE.•Monitoring monthly calibration plan and reports.•Monthly Quality Meeting, monitoring of domestic and international RMA, CAPAs, customer complains, and calibration reports.•Internal and external quality system lecturer (QMS, ISO 13485, ISO 14971… etc.). Show less

New Taipei City, Taiwan

Arrange and execute QSM audits, and the others •Prepare, review and submit technical files and 510K documents to apply EU, TFDA, Notify Body(BSI / CE0086) and FDA certifications.•Arranging 3rd party to calibrate the instruments and equipment, prepare calibration plans and reports annually.•Clean Room monitoring and product monitoring in accordance with IEC 11135 (Ethylene Oxide - Sterilization of health-care products) , IEC 11137 (Radiation - Sterilization of health-care products) ,… Show more Arrange and execute QSM audits, and the others •Prepare, review and submit technical files and 510K documents to apply EU, TFDA, Notify Body(BSI / CE0086) and FDA certifications.•Arranging 3rd party to calibrate the instruments and equipment, prepare calibration plans and reports annually.•Clean Room monitoring and product monitoring in accordance with IEC 11135 (Ethylene Oxide - Sterilization of health-care products) , IEC 11137 (Radiation - Sterilization of health-care products) , ISO 11737-1,-2 (Bioburden), Sterility test USP(71), etc. •Monthly quality monitoring meeting for CAPA reports, calibrations reports, and product sterility tests (per lot). Show less

New Taipei City, Taiwan

Review and maintain the Quality Objects and Quality Assurance Strategy annually for three plants in Taiwan, China and Malaysia.Participated and represented as Management Representative, QA Manager and Regulatory Affairs in internal audits, customer audits, notify body audits (ISO 9001, ISO 13485, and governmental audits (TFDA, FDA).•FDA Warning Letter reply and working with FDA on close out program (WL #411274, dated November 14, 2013) (Warning Letter closed on 07/21/2016)… Show more Review and maintain the Quality Objects and Quality Assurance Strategy annually for three plants in Taiwan, China and Malaysia.Participated and represented as Management Representative, QA Manager and Regulatory Affairs in internal audits, customer audits, notify body audits (ISO 9001, ISO 13485, and governmental audits (TFDA, FDA).•FDA Warning Letter reply and working with FDA on close out program (WL #411274, dated November 14, 2013) (Warning Letter closed on 07/21/2016) .•Coordinated with RD department to integrated Technical Documentation in accordance with CE 93/42/EEC and ISO 14971 Risk Management.•Interpret all the quality procedures and Technical Document into English for worldwide audits.•Represent as a Management Representative during all the quality audits, include internal audits, supplier audits, notify body audits, customer audits, FDA and TFDA audits. Show less

Ventura County, California, United States

Expending sales in domestics and international, sign up for the marketing and trade show arrangement (twice a year, Expo West, in Anaheim, CA and SupplySide West in Las Vegas, NV), GMP, HACCP, HALAL and contact FDA for nutraceutical regulation issues, import/export issues and Halal Certification.•Manage and prepare the documents to comply with GMP’s regulation and auditing. •Contact FDA for the requirements and questions regarding to regulations. •International shipment control… Show more Expending sales in domestics and international, sign up for the marketing and trade show arrangement (twice a year, Expo West, in Anaheim, CA and SupplySide West in Las Vegas, NV), GMP, HACCP, HALAL and contact FDA for nutraceutical regulation issues, import/export issues and Halal Certification.•Manage and prepare the documents to comply with GMP’s regulation and auditing. •Contact FDA for the requirements and questions regarding to regulations. •International shipment control including custom clearance and logistics arrangement. •Prepare marketing and Trade show equipment, related arrangements, and transportation.•Participate and assist in Tradeshow exhibitions.•Daily supervise of the group of customer services representatives and warehouse crews to ensure the completion of all work timely and accurately to fulfill the customer’s expectation. Show less

City Of Commerce, Ca

As a manager in trucking department, I’m in charge of trucking dispatch, trucking fee quotation, customer service and management of the department. The details are listing as below: g- Checking container availability from all the terminals in Long Beach and aligned with customer.- Driver’s manifest control and pay roll calculation.- Dispatch the trucks between container yard, terminals and customer warehouse.- Overdue trucking fee collection from customers and… Show more As a manager in trucking department, I’m in charge of trucking dispatch, trucking fee quotation, customer service and management of the department. The details are listing as below: g- Checking container availability from all the terminals in Long Beach and aligned with customer.- Driver’s manifest control and pay roll calculation.- Dispatch the trucks between container yard, terminals and customer warehouse.- Overdue trucking fee collection from customers and terminals.- Assist the driver to deal with issues, problems and arguments in the terminals or customer’s warehouse. Show less

I work in a key components control team which needs to collaborated with Project managers in ongoing projects to enhance customer satisfaction, and I’m in charge of two key components, optical Disc Drive (ODD) and Hard Disk Drive (HDD) .My duties are including following:- Co-worked with supplier’s RD team to provide technical solutions to RD team during the product development phase to help RD team to solve the technical problems. - Worked closely with other departments to promote… Show more I work in a key components control team which needs to collaborated with Project managers in ongoing projects to enhance customer satisfaction, and I’m in charge of two key components, optical Disc Drive (ODD) and Hard Disk Drive (HDD) .My duties are including following:- Co-worked with supplier’s RD team to provide technical solutions to RD team during the product development phase to help RD team to solve the technical problems. - Worked closely with other departments to promote sales quotas, codify information, and disseminate analysis reports. - Prepare weekly reports for Quanta Computer and HP teams in Taiwan, USA (Huston, TX) , and China). Show less

Master Of Engineering (M.Eng.), Bioengineering And Biomedical Engineering

Master Of Business Administration (Mba), International Business/Trade/Commerce

Bachelor Of Business Administration (B.B.A.), International Business