Glenda Tejada

mobile: 650-***-**** email: sva5vm@r.postjobfree.com

SUMMARY

Quality Assurance professional with over ten years in the medical device industry who is able to consistently maintain accuracy and quality within a fast paced environment, Experienced with document control processing, quality compliance, and sterilization dose audits, Microsoft Word, Excel, MFG/PRO, SAP, Agile, Nice Label and Solid Works.

EXPERIENCE:

CorMatrix Cardiovascular, Inc., Sunnyvale 2011 - 2011

CorMatrix Cardiovascular, Inc. is a privately held medical device company dedicated to developing and delivering innovated devices that harness the body own innate ability to repair damage heart tissue.

Quality Systems Specialist (2011 - 2011)

• Provide timely and accurate processing of ECNs including data entry using QAD

• Review of LHR, DHR for final release of product

• Final review and process of labeling

• Maintain all documentation files and provided data for management review

• Updated and maintain the Global Standard List

ArthroCare Corporation, Sunnyvale 2000 - 2011

ArthroCare is a multi-business medical device company focusing in the following surgical specialties: Arthroscopy, Spine and ENT.

Quality Analyst (2009 - 2011)

• Provide timely and accurate processing of ECNs/MCOs including data entry using electronic document systems (Agile/SAP)

• Ensure accurate input of approved data into SAP in relation to Agile (ECN new releases and changes) and SAP master data inputs

• Updated minor changes of Solid Works/CAD drawings per ECNs using the company’s databases Agile (ECN) and SAP (master data management)

• Provide Agile and Document Control procedural training to US and International sites

• Responsible for releasing and reviewing labels in the Data Base Files for US and International

• Maintain DHF files and spreadsheet

• Update and maintain the company Global Standard List

• Archived/Shipped files to offsite storage

• Lead/participate in projects/assignments that support continuous improvement efforts and department/company goal including:

• Assisted with preparations for Notified Body Assessments

• Assisted with the implementation of Nice Label database

• Participated in software validations; Nice Label, SAP, Agile

• Responsible for the Radiation Dose Audit Programs

• Coordinated microbiology testing to support product validations and launches

• Support the of E-Beam, ETO and Gamma sterilization processes

Quality Assurance Specialist II (2007 – 2009)

Quality Assurance Specialist I (2005 – 2007)

• Provided SAP training to co-workers at US and International sites

• Supported the process of ETO Sterilization and Gamma

• Coordinated microbiology testing to support product launches

• Participated in new product development activities and existing product for Sterilization Validations Reports

• Prepared samples to send for Bioburden, LAL, Gram Stain and Sterility for validations and production builds

• Reviewed reports from test labs to make sure all test was done properly and data was within range of limits

• Maintained CER environmental monitoring and review of reports

• Processed document changes in Agile/QAD to ensure electronic capture and retrieval of quality documents

• Updated minor changes of Solid Works/CAD drawings per ECN redline

• Supported SAP integration from QAD

• Created and maintain Routers and BOMs in SAP/QAD

• Maintained the Dose Audit Program

• Responsible for ensuring employee training of Standard Operating Procedures (SOP) and Departmental Operating Procedures (DOP)

Document Control Clerk II (2001 – 2005)

• Oversaw engineering change notices (ECN’s) through the document control system

• Maintained ECN history files

• Responsible for ensuring employee training of Standard Operating Procedures (SOP) and Departmental Operating Procedures (DOP’s)

• Responsible for maintaining electronic database (Access) to track employee training

Assembler I (2000 – 2001)

• Assembled sub-assemblies and finished devices per released procedures

• Visually inspected finished products for defects

• Performed labeling and packaging operations and prepared finished devices for shipment

EDUCATION/CERTIFICATIONS:

Los Altos High School, Los Altos, CA - Diploma

Radiation Sterilization for Medical Devices (AAMI)

RABQSA Certified as Auditor/Lead Auditor for ISO 13485

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