QC Inspector with Aerospace & ISO 13485 Focus
Resume:
YUVIELY MONTILVA
Tamarac FL 33321
Cell: 954-***-**** Email: *******@*****.***
EDUCATION:
Bachelor of Arts in Business Administration (BBA)
Curriculum emphasis - Marketing
Keiser University – Fort Lauderdale, FL CGPA 3.88/4.0
EXPERIENCE:
QC Assurance Inspector 10/2022 – Present
Baker Hill Industries, INC — Coral Springs, FL ISO 13485
●Examine in-progress, completed components, sub-assemblies, and incoming parts to ensure they meet quality assurance standards assessing products for conformity.
●Documenting outcomes of every individual product details and final arrangement in-house.
●Inspect all products handled according to Aerospace specifications referenced in print drawings and in reference to MOT record.
●Performing tasks on CMM and executing programs as prescribed for parts necessitating such procedures.
●Verifying documents/paper files to ensure all recorded dimensions from products at any stage of progression fall within specified tolerances and adhere to provided Aerospace specifications
●Reject components when necessary and record the actions taken accordingly.
●Maintain adherence to quality assurance Aerospace standards both within the work environment and during the transfer of products between locations.
QC Receiving Inspector 05/2018 – 10/2022
Dayton-Granger —Fort Lauderdale FL ISO 13485
●Inspect in-process, finished parts and sub-assemblies (outside process) for conformance to QA specifications. Inspect receiving parts and materials to interpreted inspection results and transfer to stock. Record Pass/Fail, product information and disposition in (Oracle) database.
●Inspect incoming parts according to blueprints and drawing requirements.
●Perform First Article Inspection. Interpret inspection results and generate reports. Perform complex inspections using micrometer, height gauge, etc. and log results in product record.
●Maintain products ISO standards and ensure proper handling of the inspection tools.
●Administer inspections for conformance to Quality and certification programs.
●Inspect and receive RMA; process to MBR for final deposition.
QC FINAL TEST COORDINATOR (Electronics) 03/2016 – 05/2018
Tridien Medical – Coral Springs FL ISO 13485
●Reviewed test documentation to verify requirements met Quality and certification programs.
●Compiled final test records into Device History Records (DHR) for each product.
●Issued product S/N to Work Orders. Assigned product S/N to Sales Orders.
●Issued Unique Device Identification (UDI) product labels to Sales Orders.
●Ensured all DHR’s went to WO Coordinators for WO closure and S/N entry (Sage ERP).
QC INSPECTOR (Support Surfaces) 05/2015 – 05/2018
Tridien Medical – Coral Springs FL ISO 13485
●Administered inspections to verify product met Quality and certification specifications.
●Maintained products to ISO 13485:2003 Medical Devices Quality Management System.
●Performed Incoming Inspection and testing of surface mount, digital/analog Printed Circuit Assemblies (PCAs). Performed Microprocessor programming, default parameter setup and Final Electrical tests of all PCAs. Monitored the equipment and procedures in the inspection process using proper handling of inspection tools. Documented all inspections and results.
●Used rulers, calipers, pin gages, thread gages, force gage, manometers, flow meters, multi-meters and automated test equipment while ensuring all instruments were in calibration and in good working order.
QC INSPECTOR (Clean Room) 02/2015 – 05/2015
Bolton Medical (Aerotek Temp) Sunrise FL ISO 13485
●Performed Quality Control inspections for a Class III medical device manufacturer with a staff of over 100 and annual sales of over $20 Million.
●Reviewed and organize Quality Management System documentation.
●Inspected Thoracic Stent-Graft (medical device implant) according to blueprints and drawing requirements. Completed Device History Record. Verified Work Orders were complete and accurate. Verified NCR documentation was complete and authorized rework.
●Determine sample size and selection method (sampling plan) based on lot size, Acceptable Quality Limit and market classification. Used accept/reject criteria to determine acceptance number and change switching rules to maintain zero-defect sampling following SOP’s
●Performed various inspections and Acceptance Qualification Tests.
●Use rulers, calipers, pin gages, thread gages, force gages, and automated test equipment ensuring all instruments were within calibration and in good working order.
QC SUPERVISOR & ASSISTANT LEAD (Clean Room) 08/2013 – 01/2015
Covidien (New Wave Surgical Corp.) – Pompano Beach FL ISO 13485
●Supervised production of three Class II FDA medical devices for Covidien, the 7th largest global healthcare products company in the world with 2013 annual sales of $10.8 Billion.
●Maintained production and quality control logs for high volume Class II FDA medical device manufacturer with individual annual sales of $44 Million.
●Ensured quality records kept per Quality Management System.
●Adhered to FDA and ISO regulations and standards for medical device production.
●Created defect reports for three medical devices. Resolved reject logs each day.
●Issued final reports after ensuring quality checks for accuracy and completeness.
●Performed daily inventory checks of materials.
●Provided day to day support and backup to 70 employees and 25 clean room stations.
ASSISTANT LEAD 07/2012 – 08/2013
New Wave Surgical Corp. – Coral Springs FL ISO 13485
●Assistant lead for production of the number one surgical device company (Inc. 500 List of America's Fastest Growing Companies, 2012 & 2013) with 2013 annual sales of $21 Million.
●Assisted and motivated employees to more than double production every year.
●Trained 35 employees in 40 production stations for clean room assembly.
●Cross trained employees to improve employee versatility to meet production requirements.
●Managed payroll leaves and PTO for all employees.
QC Assurance ASSEMBLER 07/2011 – 07/2012
New Wave Surgical Corp. – Coral Springs FL ISO 13485
●Mastered assembly of all phases of production of three Class II FDA medical devices.
INDEPENDENT COURIER (Contract) 07/2010 – 01/2011
Bank of America – Coral Springs and Miami Gardens FL
●Delivered sensitive and confidential documents and checks safely and securely.
●Coordinated pickup and organized delivery schedule to ensure delivery in a timely manner.
ADMINISTRATIVE ASSISTANT (Full Time) 01/2009 – 02/2010
Century 21 – Sunrise, FL
●Provided administrative/secretarial support for 20 people.
CUSTOMER SERVICE REPRESENTATIVE (Part Time) 4/2004 – 04/2005
Strikers Family SportsCenter – Sunrise, FL
●Provided customer service and other duties dealing with public.
ADMINISTRATIVE SUPERVISOR 09/2002 – 01/2004
National Bowling Center – Caracas, Venezuela
●Managed payroll & PTO for 12 employees. Prepared sales and expenses reports.
ADMINISTRATIVE ASSISTANT 03/2000 – 05/2002
Punto Exe Computer Store – Caracas, Venezuela
●Provided administrative/secretarial support.
SKILLS:
●Microsoft Office (Word, Excel, Power Point, Access, Outlook and Publisher), Oracle, & M-Files
●Bilingual - Spanish (native speaker) and English (Intermediate)
●Excellent interpersonal skills, phone manner, and office etiquette.
●Type 60 WMP
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