Vincent Nguyen

-Coordinate between departments to collect data related to annual product reviews (APRs).
-Author Annual Product Reviews and ensure timely completion/approval of the reports.
-Conduct timely investigations of product complaints for products produced on-site and coordinate investigations with contract manufacturing organizations for products produced off-site.
-Employ metrics and trend analyses to proactively detect deficiencies in the quality systems.
-Keep statistics on complaint reporting, including key performance indicators related to complaint processing.
-Support during inspections/audits (Regulatory Third Party, FDA) as front room scribe and subject matter expert for Annual Product Reviews.
-Initiate and oversee completion of Deviations, CAPAs, document changes and other relevant Quality System functions.
-Keep abreast of FDA and ICH guidance documents and other state and federal regulatory developments that could impact the company’s operations and report findings to the Quality members.
-Adhere to Quality management objectives/priorities and the associated action plans.

-Coordinate between departments to collect data related to annual product reviews (APRs).
-Author Annual Product Reviews and ensure timely completion/approval of the reports.
-Lead and/or support investigations into variances/non-conformances and quality issues to assure that proper changes are made to guarantee continued consistent quality.
-Conduct timely investigations of product complaints and adverse events and report findings promptly to the adverse event team.
-Employ metrics and trend analyses to proactively detect deficiencies in the quality systems.
-Support during inspections/audits (Regulatory Third Party)
-Keep abreast of FDA and ICH guidance documents and other state and federal regulatory developments that could impact the company’s operations and report findings to the Quality members.
-Adhere to Quality management objectives/priorities and the associated action plans.

-Support customer complaint management process
-Assist in ensuring complaint records are complete
-Revise procedures and work instruction documents to provide clear direction for various phases of the complaint process
-Prepare complaint data for monthly management meetings (calculate complaint rates, identify adverse trends) and present during meetings
-Coordinate with several departments to create monthly presentation for management review
-Perform complaint data searches using Agile Product Life Management software to satisfy requests from various departments including Regulatory Affairs, Complaints, Clinical Research, and Engineering
-Support external audits (MDSAP, FDA, FDA BIMO, FDB, TUV) in the front room by scribing and facilitating auditor requests
-Manage compliance projects as needed

-Handle customer complaints by making initial reporting decisions, facilitating investigations, and ensuring completeness and consistency of the documentation of the complaint
-Prepare and submit Form 3500A: Medwatch to FDA
-Monitor trends related to complaints and escalate issues to management
-Escalate complaints when new failure modes are encountered and work with OEM, Engineering, Field Personnel, and Quality Assurance to further investigate
-Analyze and organize customer complaint data for management presentations
-Perform scribe duties for several key meetings
-Provide training to new employees on product knowledge and handling customer complaints
-Support FDA audit and other similar audits (FDB, TUV, etc.)

-Provide customers, patients and internal staff via telephone and email on technical troubleshooting and product information
-Document inquiries, product complaints, service requests using company's database to be sent to headquarters for review
-Processed returned product for service/repair and/or forwarding to company headquarters for further investigation
-Organize and train new hires on products, system procedures and job instructions
-Regulatory responsibilities including Document Control and Product Hold processes