Document Control Specialist

Karen Leh

San Jose, CA *****

Document Control Specialist

Objective:

To obtain a position as a Document Control Specialist.

Skills:

PC Software Applications: MS Word, MS SharePoint, PowerPoint, Adobe, Access, Excel, and Visio.

Documentation Database: AGILE, ACONEX, E-MATRIX, EPR, DMS, GMP, QMS, PDM, and SAP.

Education:

Mission College – Santa Clara, CA.

Business and Accounting.

Work History:

Outset Medical – San Jose, CA 3/2020 – 5/2021

Quality Coordinator

-Responsible all documents are current, updates, reviews and releases, and executed to ensure compliance with current regulations.

-Preparing and maintaining quality management: MRB (Material Return Board) DHRs (Design History Records), shipping records.

-Responsible archive into Agile: DHRs, Calibration records, inspection records, receiving inspection.

-Responsible review procedures to meet regulatory and quality standard.

-Responsible Quality department weekly report and support Subcontractor

-Support internal and external quality audits.

Cobham Advanced Electronic Solution – San Jose, CA. 8/2017-6/2019

Product Info Associate / Document Control

-Responsible incorporation of approved ECN for E-MATRIC and AGILE.

-Documentation updated: BOM, initial release, document collection and Uploads to the archive system.

-Drawing check of engineering inputs, file transfer, scanning and load of documents into review files.

-Processes DCO, DCN, MCO, new Part Numbers and updated request.

-Assist CCB team with implementing Product Lifecycle Management (PLM) system, and day to tasks associated general releasing or revising support engineering and operation.

-Performs duties in support of establisted records management procedures, including scanning, filling and managing offsite records storage and retrieval.

-Responsible review Classification Engineering Changes, Deviation ensures sent to the customer for approval or / and Change Control Board review.

-ISO-9001 and 13485 support Internal and External Periodical Audit.

Carl Zeiss – Dublin, CA 8/2016 – 8/2017

Quality Management Administration.

-Responsible routine assignment DCO, SOP, Regulatory / Affairs editing, revising for reviewing and approval.

-Data entry, reviewing change orders for completeness and accuracy.

-Maintain document files: Clinical Strategy Plan Report, compliance, FDA, into Agile, Oracle, SAP, QMS, SharePoint and Global Information Master System.

-Distribution Notification of approved ECO, DCN, DCR, SOP to respectively team members.

-CAPA Review Cause, follow-up FDA procedure and correction actions request.

-Prepare and maintain DHR’s.

-ISO-9001 and 13485 support Internal and External Periodical Audit.

Omni-Vision Inc – Santa Clara, CA 1/2006 – 4/2016

Document Control Specialist

-Prepared and distributed documentation Policy, procedure, Work Instruction, Test Program Release and Datasheet for Automotive, Biometric, Camera-Cubes Chip, and Liquid Crystal on Silicon (LCOS), Medical Device, Security Camera and Smart-Phone.

-ECO, TECO, Reliability Qualification Report, Marketing Product Requirements.

-Drawings, New Product Release.

-Return Material Authorization, and support Business Expense Reports.

-Coordinate documentation editing, revising for reviewing and approval.

-Responsible Publication Notice Approval to related personals.

-Maintain ISO-9001 Document Master List and assigned new document numbers for Standard of Procedure, Policy, Work Instruction, and Form.

-Uploaded Documentation Approval into Company Portal Home Page and QA servers.

-Maintain document control files (paper, electronic, software) to all customers.

-Prepared Customer Parts Return and transmitted to Warehouse ensure updating Oracle System.

-Responsible schedule and recycling facilitate the timely operations and delivery material and services needed for scraps parts, witness and ensure payment sent to company.

-Support in QA department for Annual Audit, ensure company documentation compliance with ISO-9001.

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