Quality Systems Assurance

Jonas Delos Reyes

Ph# 510-***-****/Email: ********@*****.***

EXPERIENCE:

*/****-*/**** ******* Systems Specialist III Cepheid-Newark, CA

● Review of batch records to support work in progress, release of raw materials and final products, including reagents, components, and instrumentation-related products

● Collaborate with other function teams to resolve batch record discrepancies or errors as related to good documentation practice.

● Support the Material Review Board for the assessments and dispositions of non-conforming materials and deviation report, as needed

● Provide guidance on general quality principles and specific procedural requirements

● Assist to improve standard operating procedure and improve quality systems functions

● Understanding the general laboratory failure investigation, qualification/validation process, root cause analysis, and troubleshooting principles

● CAPA, investigation and deviation

● Qualified in closing NC and LFI

● Reviewing/releasing FG, MTB, OC, PDR, Bulk, Purchase specifications 10/2020-9/2021 Quality Control Inspector Penumbra-Alameda, CA

● Support daily inspection activities within Quality Department

● Apply basic good manufacturing practices/QSR requirements

● Read/understand engineering specifications

● Comply with documented inspection and data recording procedures

● Support R&D and production inspection activities

● Learned and applying sampling methodologies and techniques

● Maintain safe and healthy work environment by following safety guidelines and procedures

● Perform routine inspection of raw material and packaging, boxing and labels

● Provide support of First Article Inspection

● Initiate and recognize non-conformances

● Adhere to company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards and procedures

● Perform other work-related duties as assigned.

2/2020-10/2020 Quality Assurance Pulse Systems-Concord, CA

● Measure medical devices and assuring their product quality to specifications of company clients

● Involve in Material Review Board (MRB) that meets weekly

● Perform final inspection under microscope and final testing

● Conduct visual, dimensional and functional inspection, as directed by QA procedures. 4/2012-2/2020 Quality Systems Specialist Fresenius-Concord, CA

● Review device history, manufacturing and QA records

● Ensure that product maintains proper identification, traceability, and inspection and test status

● Perform general receiving, in-process, final inspection, packaging and labeling of products

● Conduct visual, dimensional and functional inspection, as directed by QA procedures

● Closely follow all procedures and specifications and accurate in performing tasks

● Employ good documentation practices in all aspects of the job. 04/2010-12/2010 Operator II-Abbott Lab ATR, Inc.-Santa Clara, CA

● Assemble medical products (called stents) used for vascular surgeries

● Drug code & place marker beads under a microscope

● Measure parts using a caliper, micrometer & ruler; Ability to read blueprints

● Troubleshoot machines when needed

● Weigh product as a final task

● Perform simple math computations.

10/2005-04/2010 Medical Assembler Medtronic Inc.-Sunnyvale, CA

● Manufacturing medical products used in Balloon Kyphoplasty (spine surgery)

● Laser and distal bonding; Measure all parts using a caliper, micrometer & ruler

● Troubleshoot machines when needed

● Ability to read blueprints and solve simple math computations

● Perform final inspection under microscope and final testing. 02/2003-05/2005 Assembly Line Operator GE Nova-SensorFremont, CA

● Assemble medical products in a clean room setting

● Responsible as the lead-attach product assembler

● Wire bond microchips with the use of microscope

● Inspect sensors and microchips after production

● Pre-test all assembled products for accurate use

● Troubleshoot machines when needed.

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