Quality Assurance Medical Device

Marlene Yvette Scoppettone

*** ****** ****** **** **********, California 95076

Phone: 831-***-**** home; 831-***-**** cell

email: acymuf@r.postjobfree.com

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Qualifications:

Coordination of document change orders (DCO) and facilities review.

Manage QMS documentation revision updates and control.

Maintain Device History Records in compliance with 21 CFR Part 820.

Assist with review/approval of manufacturing work instructions utilizing customer engineering drawings and associated regulatory documentation.

Perform both internal and external audits under the following elements: ISO 9001, ISO 13485, 21 CFR 820, 21 CFR Part 110, 21 CFR Part111, 21 CFR Part 58, EN 46001, Medical Device Directive

(MDD) 93/42/8EEC, AS9100, and Canadian Medical Device Directive.

Responsible for supplier qualification program which includes creation of risk assessment, self surveys, and SOPs, WIs and Forms.

Manage Non-Conforming Material Reports and forwarding all documentation to the internal departments and outside manufacturers that were directly affected.

Responsible for Supervising a Quality staff of 10,which included 2 Document Control Specialist and 7 Quality Control Inspectors.

Maintain records for employee training program which captures all outstanding, expired and completed training requirements.

Performed First Article Inspections and compiled FAI Reports for Medical Device Manufacturer, which included final review of all Sterilization Data.

Quality Inspection for mechanical components (injected molded plastic and stamped metal), PCB’s, and Printed Circuit Assemblies.

Manage internal Corrective Actions and issue Supplier Corrective Actions

Calibration Coordinator for all test and measurement equipment, working closely with outside calibration labs.

Employment History:

4/15 - Present Plasma Ruggedized Solutions, San Jose CA; QA Systems Administrator 6/14 - 4/15 QoStronics, Inc, San Jose, CA; QA Specialist 1/13 - 5/14 AGC AeroComposites, Marina CA; QA Systems Administrator 9/11 - 1/13 Santa Cruz Nutritionals, Santa Cruz CA; Quality Assurance Specialist II 5/10 - 6/11 Intuitive Surgical, Sunnyvale CA; Document History Record Administrator 7/06 - 5/10 Fox Racing Shox, Watsonville CA; QA Specialist 9/05 - 7/06 Xyratex, Scotts Valley CA; Quality Assurance Inspector 11/04 - 9/05 Pacific Plastics and Engineering, Soquel CA; Quality Assurance Lead 4/04 - 11/04 BC Tech, Santa Cruz CA; Document Control Assistant 7/02 - 1/04 Parallax Medical, Scotts Valley CA; Quality Control Inspector Marlene Yvette Scoppettone

270 Eureka Canyon Road Corralitos, California 95076 Phone: 831-***-**** home; 831-***-**** cell

email: acymuf@r.postjobfree.com

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Technical Skills:

Proficient with MS-Office, (Word, Excel, PPT), Filemaker Pro, Agile, SAP, SharePoint, Acrobat

MRP systems: IQMS, Epicor Vantage and SAP.

Utilized the following software to work with various CAD fabrication drawings: DrDraw

(AutoCAD viewer), Pro Engineer, Pro-Tel, Lavenir (gerber file viewer), Camtastic, and Solid Works.

Experienced with use of Nikon Optical Comparator, calipers, micrometers, measuring microscope, gage blocks, and gage pins.

Training:

RABQSA-Certified AS9100: 2009 Lead QMS Auditor Training-Certificate of Completion

RABQSA-Certified ISO 9001:2008 Internal Auditor Training w ISO/TS 16949: 2009 Automotive Emphasis- Certificate of Completion

Enterprise IQ Quality Training- IQMS Certificate of Completion

General Industry OSHA Course-Certificate of Completion

Sterilization Validation for the Medical Device Industry- ASQ Course Completion Certificate

Geometric Dimensioning and Tolerance Course

Blue Prints Reading Fundamentals

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