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Additional Engineering Resume Samples
Qa Specialist Resume Samples
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0-5 years of experience
- Responsible for review the Device History Record of External Complaints (Critical Care, Vascular and CDP).
- Analyzed the NCR (Non Conformance report) and other events during the manufacturing process to establish if exist, any relation with the external complaint.
- Generated ECR to change Document Owner, revised procedure and forms.
- Administrated the documentation (procedures, forms, drawings) sent and receive from external client.
- Successfully improved the Edwards Learning System (ELMS) by assigning each client as an employee making the process of receiving notifications easier and reducing all paper work.
- Successfully reduced the cycle time of reviewing a Device History from 12 to 3 days in the first year by implementing a priority report that were received daily and adding the revision of the subassemblies records used in the manufacturing process. In the last year, the days were decreased from 3 days to less than 1 day.
0-5 years of experience
- Executed internal audits to ensure compliance with ICH Good Clinical Practices, EN ISO 9001/ISO 13485 and applicable regulatory requirements
- Performed tracking/trending analysis of quality findings and assist operations in the implementation of corrective action plans
- Managed department-wide process harmonization projects after a merger
- Conducted training and developed and managed work instructions, presentations and training documentation
- Managed a database of quality program records, and metrics
- Developed departmental procedures to align workflows and improve process efficiency
- Generated quality reports, white papers and standardized documentation for delivery to clients
0-5 years of experience
- Proofreads projects consists of medication inserts, outserts, cartons, labels, pouches and tubes using Illustrator, InDesign and Text Verification Tool (TVT)
- Received a TVT certification and quickly became the single point of contact regarding any question or problems using the tool by the team
- Solely responsible for checking thoroughly written and printed materials then providing feedback and marked errors back to the designer
- Works quick and efficient with a very rapid turnaround communicating effectively with team members
- Works closely with my team members day to day discussing existing and future projects delivering them before they are due
0-5 years of experience
- Improved functionality & workflow of existing site using knowledge of UX/UI & customer feedback.
- Created & executed test cases & cross-browser compatibility matrix to document testing results.
- Performed manual & gray-box testing in an agile environment, including system, performance, regression & stress testing.
- Optimized the testing process in collaboration with management & engineering teams.
- Received positive performance review and full-time offer as SQA Analyst (respectfully declined to accept QA Engineering role at Apple).
0-5 years of experience
Create patient accounts demographics provided by different facilities.
- Reconcile batches to ensure claims are billed in a timely manner with no errors.
- Verify patient insurances provided by hospitals.
- Run concurrency reports for different facilities.
- Meet daily deadlines and input needed statistics into spreadsheets as needed.
- Follow up with facilities to get missing data for accounts
0-5 years of experience
- Perform domestic and international regulatory assessments for pharmaceutical products
- Author, review, coordinate, and prepare documentation packages for regulatory submissions.
- Draft SOPs, CAPAs, DCR and batch records. Explained in simple language scientific and technical ideas that are difficult for the average reader to understand.
- Manage Customer complaints and post market surveillance, including product defect investigation and inspectional support.
- Conduct internal and supplier audits
- Administering the quality system ensuring compliance with the US medical device GMPs (21 CFR 820), ISO 13485:2012.
0-5 years of experience
Responsible for validation of AMISYS claims processing software
- Translate client feature requirements into test cases and articulate discrepancies between actual and expected results.
- Design and document reliable test cases based on software feature requirements
- Document problems and events using web based applications such as AWD and JIRA
- Review and provide feedback of processes and of completed tasks of associates
- Ensure that associates provide the highest quality services to customers
- Work on complex projects that provide reports to management
0-5 years of experience
Conduct/perform internal and external audits: plasma centers, manufacturing facilities
- Conduct and assist customer and FDA audits
- Analyze and prepare annual product reviews
- Quality liaison between outsourced packaging facility (CMO) and manufacturing facility
- Process and release of raw materials
- Performed releases for customer plasma pools, RBC shipments
- Conduct investigation customer complaint system from a Quality stand point
- Final product documentation/system review for product disposition
- Documentation/system review for raw material/components release for manufacturing
6-10 years of experience
- Retrieve and inspect totes of automotive supplies and forward to shipping department
- Count Inventory and fix high shrink problems
- Manage inventory of Warehouse
- Maintain accuracy of parts being received and audit accordingly
0-5 years of experience
- Conduct and request investigation of product complaints, review complaint samples, retained reference samples, deviations, manufacturing records, and complaint histories or trends
- Identify possible root cause and any other corrective actions
- Technical writing investigations in accordance with established industry procedures
- Proficient in PCOM and Trackwise database and Quality Management Systems; knowledgeable of Annual Product Evaluation Reports (APER), Excel and report trending, knowledge on CAPA process, and suppliers management
- Support audit team and change control processes across manufacturing, packaging, and warehouse facilities
- Train personnel of the functions and responsibilities of the position
- Participated in a special project for to prevent possible product mix ups advising to use different forms of prevention along the manufacturing and packaging areas. This project was part of a Zero Defect project that is currently in progress
- Supports and enhance quality compliance systems and objectives within site
- Maintains quality mindset and implements continuous improvements efforts and quality system initiatives to industry requirements
- Represent QA during staff meetings
6-10 years of experience
Review accuracy of patient charge activity abstracted and coded by the certified coders as billable charges to the patient's insurance plan or to the patient if uninsured.
- Verify the accuracy of the physician procedure count to ensure all slips were coded by the coder and verify the number of cases charged agree with the number of anesthesia cases for each physician by date of service.
- Correspond with physicians in regards to discrepancies on Medical Records to ensure proper billing.
- Verify the accuracy of the charge worksheet journal to the batch origination count and surgery schedule; initiates generation of the system concurrency reports; stores various documents used/created during the batch reconciliation process in the shared system file folder(s); and records batch charge totals on the MedSuite Balancing Log by client or site location
- Ensure all anesthesia charges are correct in order to avoid missed revenue or a delay in revenue.
0-5 years of experience
- Consoles used: Xbox One, Pc, and iPhone
- Analyzing video games for errors, bugs, and ways for improvement
- Writing Bug reports
- QA for AAA Titles
0-5 years of experience
- Perform linguistic reviews on an average of 25 localization projects per week, many to be completed within 24-72 hours.
- Work closely with customers and technical personnel to develop and uphold strict consistency standards
- Participate and assist in demanding Language Acceptance Testing (LAT) group linguistic sessions
- Assisting the project manager
- Understanding and discussing what the customer wants to be tested
- Writing the test script and defining the test content
- Checking for and resolving bugs that were logged via tools such as JIRA
- Helping to prepare mobile devices for testing
- Preparing and sending audits for vendors
0-5 years of experience
Communicate with co-workers to get job done.
- Review documents in detail for accuracy
- Work on computer correcting documents.
- Process documents for next step in delivery or pick process.
0-5 years of experience
- Process and Reconcile child support payments for the State of Michigan
- Daily deposit and entering of all child support payments in form of check, 10 key.
- Access to company systems and programs. Experience with Excel and Microsoft Word for daily functions
0-5 years of experience
- QA all SN notes to ensure all documentation/ VO's are being followed
- Write VO's for therapy frequency
- Audit Oasis to ensure compliance/ complete POC
- Contact nurses/ therapist to complete documentation needed
0-5 years of experience
- Act as a quality intermidiate between customer service and suppliers for the distribution chain.
- Quarantine Products for U.S product for stock check, warehouse recovery, customer recovery and customer advisory.
- Review submitted urgent product complaints and organize investigation response letters to medical devices, private label, importer of record, and child part items.
- Use MasterControl, Mainframe, Cognos,OnDemand, iRIMS, QRRShare, to manage product.
- Implement change notifications for products.
- Assemble team metrics for quarantines, complaints.
- Create and Edit Work Instructions and SOP's for Customer Channels group
- Coordinate with supply chain, product managers, buyers, legal teams for injury reports.