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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