Quality Assurance Medical Devices

Jay Santos Rocha

**** ***** ** *** *** *B Morris Plains, NJ 07950

Cel 484-***-****

*********.******@*****.***

WORK EXPERIENCE

Siemens Healthcare Diagnostic

Manufacturing Tech RMS / DFL -2011Production Worker 2/ FAOSPTE12-Floor Assembly Operator -Semi-products Flanders NJ 9/17 preset

Build and test RMS part of Dimension instrument.

Perform test acording specific requirements

Mechanical/Electrical Assembler in Medical Devices.

Inspected parts to ensure that they met specific Engineering Instructions.

Produced and Assembled parts for the final assembly Line.

Fabricated parts using hand tools where necessary.

Enforce technical quality assurance guidelines.

Trained line Operators in specific areas for DIMENSION process.

Follow FDA, TUK- SUD AND ISO guidelines for build and test Medical Devices.

Testing and fixing trouble shooting in Sub Assy.

Refurbishing Instruments.

Samblasting machine

Sand blending, polsishing in to the machine shop

Cycle Count with SAP System.

Quality Document Control.

Electrical Safety

TRAINING CERTIFICATES COMPLETED WBT- SIEMENS HEALTHINEERS 2017-2024

Good Manufacturing and Laboratory Practices

Good Documentation Practices GDP

Qualified Electrical Worker 3.0

Safety ESD Shoe Procedure

Emergency Response Plan

Electrostatic Discharge Control Program for Manufacturing

Biohazard Exposure Control Plan

5 S Procedure

Waste Management

Lean Six Sigma Black Belt

Violence in the workplace- How to prevent and Defuse for Employees

Stress Management

Workplace Security for employees

IED Training Work instructions

Operation and Maintenance of Environmental Monitoring System

Quality Record Retention Policy

Nonconformace Procedure

Procedure for Control of Production Material with Special Requirements

Cybersecurity Awareness Training

Production Line Supervisor And Production Quality Inspector 01/16 – 08/17

Multipack Packaging, West Caldwell NJ

Supervised production lines with 30 – 35 line Operators.

Train line operators and quality inspectors in production, mechanical, and quality job requirements.

Followed FDA guidelines in filling and packing medical products.

Complaied with GCMP processing guidelines.

Monitor and enforced SOPs and CGMPs’ compliance.

Accept/reject in process and finished goods.

Supervised and cleared production line startup.

Ensured that production documentation is properly completed and signed.

Conduct and document complaints, investigations and deviations.

Assess and enforce technical quality assurance guidelines.

SMT Operator/ Screen Printer Operator/ Tech Operator/ Assembler 03/15 - 10/15

PNY Tecnologies, Parsippany NJ

Certified SMT computer memory board machines operator.

Operated Surface Mount Machines according to the standard operating procedures FUJI and PANASONIC

Perform machine set-up and maintenance according to their documented procedures.

Set-up Feeders for SMT pick and place machines.

Operate SMT MyData pick and place machines.

Hand Place SMT parts on stenciled boards.

Set-up and operate manual and MPM stencil printers.

Communicate machine operation status to management as needed or required.

Troubleshoot defective memory boards, USB and hard drives.

Performed technical and quality control requirements.

Prepared shipment orders.

Assembled and sold computer components.

Test Memories RAM and Spliders and Video Card.

Laser Machine Operator.

Team Lead/Supervisor

Unette Corporation, Randolph NJ/ Staff Managenet Group 01/13 -11/13

Food Depot Supermarket and Bravo Supermarket, Newark NJ 7/11- 8/12

Network Solutions, Miami FL

5/10- 6/11

Trained and supervise personnel.

Verify materials, supplies, and orders accuracy.

Managed Smartlock Computer Program.

Input product pricing in database.

Installed computer programs and internet service.

Repaired and maintenance computer software and hardware.

OTHER EXPERIENCE

Driver for State Shuttle 2023

Driver for Action Group/ Enterprice Shuttle Van 2019 -2021

Driver for Edibles Arregmentes for delivey 2016-2021

Amazon Driver 2018

Uber Driver 2017-2019

EDUCATION

Certified Nursing Assistant, Merry Heart New Jersey 2012

Systems Engineering UNAH Honduras 2009

Certification in Micro Economics, University Of Nicaragua 2005

Bachelor Degree in Social Work, University Of Nicaragua 2004

Technical in Help Desk Support, TEC Nicaragua 2003

Ceritified in Leadership and GPS, Armed Forces Nicaragua 2002

Technical in Computer Operator, TEC Nicaragua 2001

SKILLS

Bilingual English/Spanish. Proficiency in computer, Microsoft Office, IED, electronic and mechanic, ability to read electronics schematics and blue prints. Quick learner, coaching and teaching aptitud, team player, time and people management, analytical and logical thinker, flexible, multitasking, conflict resolution, problem solver, detail oriented, have been a significant part of successful troubleshoothing activities, leanding to more efective corrective actions and implementation of new improvements, very motivated.

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