Preparation & review of company & supplier PPAP’s, CDP’s & SCRs as that apply to the Tri-Staple supplier expansion project. Project goal is to provide an increase of 1/3 of availability of suppliers, components & assembles to provide increased product to market availability.Reviewed and updated internal tracking of CDPs as to provide a more efficient & focused effort bring product to market.Review FAI’s as required per the Medtronic Global PPAP standard operational procedure as well use of the components / assembles via the companies AGILE - ERP system.Provide training & support to the other SQE Team as needed & required.

Development, Implementation & Oversee the company’s installation of AS9100Dand ISO 9001:2115 Quality Management Systems.Interface with the 3rd party advisor to create the companies Quality Manual, Calibration system, Standard Operating Procedures (SOP’s), Work Instructions and all related forms and records of documentation related to them.Cleaning up the shipping &receiving , material handling MRN & manufacturing floor using 5S techniques to assure that the company meets the AS9146 call out for FOD prevention.Create, Schedule & Carry out JVP’s internal auditing of the shop floor, management, calibration, inspection and all other related process’ as called out by the AS9100D & ISO 9001:2015 requirements.Through the use of GAGEtrak 7.04 software initiate an issue & recall calibration system that is up to date for AS9100D & ISO 9001:2015.Implement the related AS9101 - 1st article inspection paperwork & retention of inspection records.Adhere to the schedule put forth by our 3rd party to get the company there AS9100D certification by 7/1/ 2018.

Calibration of hand tools and hard gauging. Observation of areas of improvements for safety and efficiently.Interaction with Eaton personnel to obtain the above.Issuance of monthly and daily gage recall lists.

Lead Quality Person in charge of the Company's Wallingford Ct site ISO 9001 & SIO 13485 Quality Managements Systems.

Provided a GAP assessment to overhaul of the company’s current QMS.Lead the companies AS9100D / ISO 9001: 2015 Quality Management system audit with 2 minor non-conformances that have been addressed and been corrected.Presently leading the companies Continuous Improvement efforts to eliminate wasted time & efforts with the Manufacturing, Shipping & Receiving, Quality and Purchasing departments.Lead Internal Auditor & Manger of the company’s improvement project to have a mor robust & responsible Internal Auditing program.Developed & implemented anAS9100D compliant Counterfeit parts, products and material awareness SOP & training to comply with customers’ requirementsUpgrade the companies gage calibration system and implementation of Gagetrak Lite to better comply to AS9100D requirements.Generation of critical KPI’s that better define the company’s Supplier on Time Delivery data & Supplier Rating methodology.Networking of Incoming Materials – MFG – In-Process – Out sources –and shipment of Quality approved customer products.Delivered an updated QMS Management Review report format as required via AS9100 D / ISO 9001: 2015 that was recognized during the AS9100 D surveillance audit as being very detailed and advanced than others the auditor had reviewed in previous audits.

Provided a GAP assessment to overhaul of the company’s current QMS.Lead the companies AS9100D / ISO 9001: 2015 Quality Management system audit with 2 minor non-conformances that have been addressed and been corrected.Presently leading the companies Continuous Improvement efforts to eliminate wasted time & efforts with the Manufacturing, Shipping & Receiving, Quality and Purchasing departments.Lead Internal Auditor & Manger of the company’s improvement project to have a mor robust & responsible Internal Auditing program.Developed & implemented anAS9100D compliant Counterfeit parts, products and material awareness SOP & training to comply with customers’ requirementsUpgrade the companies gage calibration system and implementation of Gagetrak Lite to better comply to AS9100D requirements.Generation of critical KPI’s that better define the company’s Supplier on Time Delivery data & Supplier Rating methodology.Networking of Incoming Materials – MFG – In-Process – Out sources –and shipment of Quality approved customer products.Delivered an updated QMS Management Review report format as required via AS9100 D / ISO 9001: 2015 that was recognized during the AS9100 D surveillance audit as being very detailed and advanced than others the auditor had reviewed in previous audits.

In process and final inspection of complex machined Delrin® Acetal Resin, PCTFE , Polypropylene, FEP, PFA and Tefzel® ETFE manifolds, parts, assemblies and sub-assemblies.Inspections completed by the use of hand tools (mics, calipers thread gages etc.) Smartscopes, optical comparators and manual CMM’s.Manufacturing process’ and operations documented and tracked by the use of Vantage documentation software package.Production of Confirmation of Certification and inspection test data upon customer requirements. Filing of all related paperwork for each job inspected.

Inspection and qualification of Pratt & Whitney jet aircraft engine gear box assemblies GG4 & GG8. Visual, mechanical and dimensional inspection of sub-assemblies, internal and or external components related to the quality of the related inspection requirements. Use of the company’s inspection protocols and related internal and vendor services notices.Documentation and retention recorders of all the status of each inspection plan. Including accepted, scrapped and reworked components.Inspection of jet aircraft engine bearing and being assemblies to assure the compliance to WGPW and customer industry and safety compliances.

Perform, coordinate and maintain all of the companies in house and outsourced gauge calibration efforts to meet ISO, FAA, ASQR and AS 9100 requirements.Maintenance of the companies gauge calibration system via the software package Gagetrak ver. 6.7 and NIST traceable calibration standards.Hands on verification and calibration of the companies Titanium Hot forming presses, Product Heat Treat Ovens, Materials Lab Ovens, Plastic, Rubber and Polymer Molding machines.Also the associated systems for temperature control, temperature recording. As well as the traceability and reliability of those systems.Calibration and verification of Triple Beam Balances and Digital Electronic weight scales.Calibration and Verification of all hand tool such as MIC’s, Calipers, Plug Gauge EST.Calibration of the company’s pressure gauges that are associated to the companies Titanium Hot forming presses, Lab Ovens, Plastic, Rubber and Polymer Molding machines and associated systems.Maintenance of all the companies gauging concerning the form fit and function of produced aerospace components.Participation in the AGC Acquisition LLC’s - AS9100 2013, 2014 and perpetration for 2015’s qualification audit and continuing improvement efforts.Participation in the company’s ASQR-01 quality system audit 10/2014 which yielded 4 very minor write ups.Active monthly internal auditing of the various company manufacturing and quality cells for compliance to the company’s internal quality system and requirements.Testing of the companies’ elastomers, composites and raw materials in the companies Materials Verification Lab. This was done by the use of Tensile, Heat Treating cold exposure methodologies. (ASTM, ASM EST.)

Performance of reliability and verification testing on a verity of mechanical and electro-mechanical surgical instrumentation. Via instruction of the R&D engineering staff and departmental operational procedures Theses responsibilities included dimensional inspection, mechanical testing, electrical performance and software interfacing. Use of TesaVisio Vision V300 video tool scope with Testavesta 1.4.3 inspection software. Test Resources material testing system using MTL 800L material testing software. Use of inspection hand tools ( mics, calipers est. )Mechanical and dimensional measurement testing of prototype medical devices and components. Generation of test procedures, protocols and test data related to the testing preformed.Calibration of in house gauging where applicable. Coordination of gauging needing calibration via an outside source. Documentation and recording of calibration records.

Inspection of precision machined aircraft components too company blue print and quality standards.Inspection methods include the use of hand tools (calipers, micrometers, and thread gages) company gauging and visual inspection as required by the work order operation.Review of the operation needed to be checked on the work order that is reprehensive of the components(s).Determine if the components are discrepant or compliant to said blue prints and quality standards.Process the paperwork and components that are determined to be compliant and move them on to the next operation.Write discrepancy reports via the companies DR system using the Solumina tracking system.

Performed 1st article, 1st piece, and non-routine inspections of molded plastic, stamped, formed or cast metal parts. These verifications were performed using non-contact video inspection systems (RAM optical, OGP Smart Scope, Nikon Tool scopes), surface plate lay out inspection and standard inspection hand tools. Hardness & Micro-Hardness testing using Wilson / Rockwell Series 500 hardness tester and Wilson Tukon 200 series micro-hardness tester.Qualification and calibration of measurement instrumentation.Developed and implemented of an in house load/force calibration program to meet ASTM E4 and E74, NIST & ISO 9000:2001 requirements for all in house universal material testing systems. Developed, implemented and documented all non-routine mechanical testing procedures for components, sub-assemblies and fully assembled surgical devices. Developed test methods, techniques and custom testing systems for the company’s suture wound closure products. Coordinated and documented all of the companies' material testing methods to ensure repeatable, reproducible test data and methodology between all Q.A. areas. Assisted in the IQ / OQ process to validate each test system and software version used on for piece of testing equipment.