Quality Service
Resume:
LOWELL, MA. *****
978-***-**** ***********@*****.***
NGOR LENGSAVAT
SUMMARY OF QUALIFICATIONS
Extensive background in Quality Assurance, Medical Device, Electronics, Computer HW/SW, Network Communications.
Over 15 years combined Quality Assurance, Technical, Technical Service, and Support experience.
Experience in Quality Complaint Handling, Reporting and Trending.
Knowledge of regulations, safety standards, and regulatory and compliance guidelines.
Familiarity with FDA Title 21, CFR820.100, CFR820.198, CFR803, ISO 9001, ISO 13485:2016, ISO 14971:2019, and other medical device regulations.
Exceptional ability to handle multiple tasks and conduct with accuracy and high attention to detail.
Strong ability to plan, schedule, and prioritize own work routine to meet established goals and support activities of Department.
Perform job functions in every project at the highest level possible.
Excellent written, verbal communication, and interpersonal skills.
Willingness to co-operate with others and work for the greater good.
Skilled in Troubleshooting, Root Cause Analysis, and Data analysis.
Proficient with all Microsoft Operating Systems, Microsoft Office Suite, SAP, Trackwise, MES, Infomed, Salesforce, Windchill etc.
Ability to learn any work related software program almost instantly including all CRM platforms.
Able to install, configure, monitor, upgrade, and maintain HW/SW related to network infrastructure.
WORK EXPERIENCE
Feb, 2018 – May, 2019 Mobius Imaging Inc. Shirley, MA
Quality Assurance /Complaint Handling Coordinator
Manage the handling, investigation, and resolution of all product performance complaints and patient-related field events in a manner that complies with regulatory requirements.
Responsible for all aspects of the Complaint Handling process of Mobius Imaging’s CT Imaging Systems.
Review Feedback Cases from a variety of sources and make determination on whether it is a Complaint Case.
Collaborate with Field Service Engineers, Technical Support Engineer, International Representatives, and customers to complete complaint analysis and compile investigation results.
Investigate all Complaint Cases related to product quality and patient safety.
Review completed complaint files to ensure compliance to business requirements as well as regulatory
requirements.
Make sure all documentations associated with the Complaint is accurate and ready to be filed within a timely manner.
Drive product quality improvements and support quality-based processes to ensure the high-quality products and solutions, as well as compliance with all applicable regulations and requirements.
Identify any areas of non-conformance with the CT Imaging System.
Member of the Risk Management team with Representatives from Regulatory Affairs and Technical Service Department designated to identify, evaluate, and assess potential risk of product.
Support and participate in internal and external audits, risk management summaries, and health hazard evaluation.
Aug, 2016 – Apr, 2017 Zoll Medical Corporation (Contract) Chelmsford, MA
Quality Assurance /Product Complaint Handling
Evaluate, investigate, track, and complete complaint investigations.
Maintain complete complaint files for all customer complaints, according to procedures and instructions.
Evaluate, standalone accessories, generate NCR and document results and findings in MES/Informed and Oracle system.
Review product investigations for completeness and to establish root cause as required (system level and/or component level).
Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
Overall review for completeness, accuracy, and release of device to customer.
Participate and collaborate objectively with productive conclusions in the complaint handling meetings.
Identify areas of potential noncompliance within the Product Complaint Process.
Prepare responses to customers and field representatives as necessary.
Monitor guidelines, collect process and quality data to determine trends and identify potential risks.
Propose corrective action on an as needed basis.
June, 2014 – Jul, 2016 Philips Healthcare (Contract) Andover, MA
Compliance Specialist / Product Complaint Handling
Responsible for assigned complaint investigations from evaluation to closure in accordance with internal and external regulatory requirements.
Investigate customer complaints related to product quality and patient safety.
Utilized Database software such as SAP, Trackwise, Salesforce, eDHR, eDMR … etc for data mining and queries to analyze data.
Perform root cause analysis and identify resolution of assigned complaints.
Collaborated with Field Service Engineers, Product Support, International Key Market Representatives and customers to complete complaint analysis and compile investigation results.
Identify potential safety problems.
Investigate complex clinical and technical issues.
Present data in a clear and concise manner in accordance with Standard Operating Procedures into the complaint record.
Prepare responses to customers and field representatives as necessary per process.
Complete investigations in a timely manner.
Review and approval of nonconforming material documentation.
Perform other duties as assigned.
Dec, 2015 – May, 2016 Boston Technology Research Boston, MA
Computer System Validation Associate (Part Time)
Development and deployment of Quality Systems, and process controls, and continuous improvement methods.
Tasks include audits/gap analysis, risk assessment of systems, remediation planning and associated coordination efforts for existing comparable system solutions.
Prepare process/cleaning validation protocols and summary reports for new and existing products.
Implement validation guidelines and create document packages for all validation assignments.
Assist in performing process evaluation using statistical tools and perform trend analysis.
Coordinate with Manufacturing and Quality Control to obtain results for writing reports.
Author and revise applicable Standard Operating Procedures (SOPs) as required.
Participate on cross-functional team that address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.
Assist validation supervisor in all validation plans for projects.
October, 2010 – June, 2014 St. Jude Medical Inc. Westford, MA
Senior Technical Service Specialist
Process Return Material Authorization (RMA) receiving equipment into Service Department.
Service, Repair and refurbish Optical Coherence Tomography Medical Imaging Systems and sub-assemblies.
Perform root-cause analysis, repair, upgrades and testing of product and systems that return from field.
Perform Preventive Maintenance and Calibration on all test equipment in Service Department.
Responsible for all PC operations for repairs and refurbishment. (e.g. PC troubleshooting HW& SW, HW replacement, Imaging, SW installation, configuring, network connections etc.)
Complete all necessary Service and Quality documentation required for returned product.
Assist in maintaining organization within Service Department.
Participate in the authoring of technical documents related to the repair, upgrade, or testing of returned product.
Assist in Product, Equipment, and Process Validations and Verifications.
Work with various departments (e.g. Engineering, Manufacturing, Quality, Software) to ensure product meets standards of regulatory organizations.
Train employees in new test procedures, repair methods, assemblies etc.
Provide technical support via Phone and E-mail to Customers, Field Service Reps, and Sales Representatives.
EDUCATION
02/2008 – 05/2009, Lincoln Technical Institute Lowell, MA
Network Communication & Information Systems
09/2000 – 05/2001, Middlesex Community College Lowell, MA
Computers and Telecommunication Technology
09/1991 – 06/1995, Lowell High School - Graduate Lowell, MA
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