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Complaint Handling Specialist

Location:
Rialt, California, 92376, United States
Salary:
$16 per hour
Posted:
June 17, 2009
Email:
pmaezs@r.postjobfree.com
Contact Info:
**********@*****.***


RENEE K. ATTAR

Rialto, California *****,

pmaezs@r.postjobfree.com, (909) ***-****

OBJECTIVE: To obtain a position as a Product Compliance Assoicate enhance to enhance the productivity and profitability in a financially stable and prestigious company.

EXPERIENCE:

NOBEL BIOCARE USA LLC, Yorba Linda, Ca 10/4/99 – 4/3/09

POST MARKET SURVEILLANCE ANALYST

• Reported all MDR (medical device reporting) decisions to the FDA

• Reported MDD/MDV/Vigilance (medical device reporting) decisions

• Investigated all product complaints and Osseo failures of dental implants

• Pulled retain samples and DHR (device history records) reports

• Inspected retain samples against product complaint part(s) returned

• Requested CAPA reports (corrective and preventative action) to prevent same occurrence

• Contacted doctors by phone, fax or e-mail for additional information needed to process their complaint(s)

• Wrote response letters to doctors if they requested evaluation results regarding their complaint(s) submitted

• Emailed and phoned subsidiaries to address international complaints and the end result of all the investigations

• Trained new hires and transferred personnel

• Shared and/or trained information I learned in seminars with coworkers

• Pulled files, procedures and other necessary documents needed to prepare for audits

• Communicated and worked with various departments to help internal and external customers

• Worked with vendors to order needed supplies within QE department

• Was responsible for managing customer returns as senior inspector

• Researched Internet for competitor’s parts, warning letters to FDA, reporting to FDA and checked their mid-watch reports, as well as bench marketing (compared competitor’s procedures, objectives, sales)

• Used following software and devices: SAP, Windows 2000, Microsoft Word & Excel, Access, worked with microscopes, took pictures of parts and used various types of measuring equipment, read blue prints

ULTIMATE STAFFING, Brea, Ca for NOBEL BIOCARE. 2/99 – 10/99

CUSTOMER RETURNS INSPECTOR

• Sterilized all open parts received

• Entered incoming returns into a database

• Inspected returned parts

• Received and assisted incoming calls from customer support and accounting department

• QUALITY ASSURANCE

• Worked with various measuring tools

• Worked with accounting group to ensure customers received proper credit for parts returned

• Supported Post Market Surveillance Dept. if a recall occurred by obtaining all the returned recalled parts

• Was responsible for updating procedures, work instructions, and preparation for audits

THOMAS STAFFING, Santa Ana, Ca 9/98 – 10/98

RECEPTIONIST

• Assisted in conducting new car preference surveys

• Handled all incoming and outgoing phone calls for a company

INTERNATIONAL TEMPORARY AND PERMANENT SERVICES, Stanton, Ca 10/97 – 8/98

EMPLOYMENT RECRUITER

• Was a receptionist that welcomed new job seekers

• Controlled employee applicant flow and daily journal

• Answered all incoming calls with six busy phone lines

• Performed data entry, faxed, collated, filed and proofread

• Used Windows 95, Windows 97 and Word 97

• Worked with Employment Development Department for State of California to recruit

• Worked with Immigration Nationalization Service to confirm Legal Residency and Citizenship for Employment

EDUCATION

Valley Community College, San Bernardino, Ca – Earned 4.0 GPA, 01/08-Present

Fullerton College, Fullerton, Ca -08/03-12/03

Rio Hondo College, Whittier, Ca- 01/03-06/03

Mount San Antonio College, Walnut, Ca - Earned 8 units in Early Childhood Development

San Dimas High School, San Dimas, Ca – High School Diploma, Graduated 6/1987

CERTIFICATIONS:

SCHOOL OF CONTINUING EDUCATION, ANAHEIM, Ca

• Introduction to the Medical Device Industry- Earned 3 Certificates, 4/15/08

• Overview of FDA’s Medical Device Regulation, 4/16/08

• Fundamentals of GMP and QSR, 4/17/08

• Quality System: ISO 13485:2003 Basics- Earned 2 Certificates, 4/18/08

ASQ QUALITY IMPROVEMENT ASSOCIATE

• Certification Number: 5684, 12/01/2007

VITAS CERTIFIED VOLUNTEER

• Program 92-Inland Empire

SEMINARS:

• American Management Association.: How To Take Charge of The Front Desk, 0.6 CEU, 3/98

• Robert E. Spivock Consultants: Good Manufacturing Practices for Medical Device Industry, 0.5 CEU, 10/1/03

• ASQ Certified Quality Improvement Assoc. Refresher Courses (Recertification Units), 2.0 RU, 02/28/2006

• ASQ Quality Learning Series, 1.50 CEU, 8/25/05

• RAPS Medical Device Postmarked Issues Web cast, 1.5 CEU, 11/06

• ASQ Quality Management Conference, 18th Annual Management Conference, 3/3/08

• OCRA MDR Regulatory Network Meetings, 4/04

• Attended monthly meetings with Christine Posin (recommended by Vice President Al Gore as expert in FDA Complaint Handling Processes and Procedures) from April 2004 to 2009

• Each seminar earned 1.5 hours for certification/recertification certificates.

Professional References Upon Request