Customer Service Quality Assurance

Marielena (Mary) Carvajal

***** ******* ***, **** ******, CA 92630

Home 949-***-**** / Cell 714-***-**** (preferred number)

***********@*******.***

Summary: Bilingual (English/Spanish), highly skilled, and self motivated with over 20

years of experience in the medical device industry. Possess strong background in Quality

Assurance and Post Market Surveillance, as well as excellent verbal and written

communication skills. Highly organized with good technical knowledge and excellent

leadership skills in a team setting. Highly experienced in trouble shooting with a high

volume, fast-paced manufacturing environment.

Experience:

Manager, Global Product Surveillance & Safety 03/2008-Present

Eyeonics/Bausch & Lomb, Inc. - Ophthalmology Aliso Viejo, CA

•Responsible for Global Complaint Handling Process, including management review & audit

representative

•Successfully represented multiple FDA inspections with zero observations

•Successfully represented multiple Corporate & Notified Body inspections with zero

observations

•Responsible for providing guidance, leadership, oversight, performance reviews and

mentoring of direct reports

•Responsible for ensuring site compliance with FDA, European, Canadian, and Other

International Regulations

•Responsible for MDR/Vigilance determinations and filings in a timely manner to

appropriate agencies

•Support CAPA, Document Control, Return Product and Quality Improvement project

activities

•Provide complaint handling related support & training to Clinical/Customer/Field Services

and Management as required

•Responsible for Complaint Trending

•Responsible for revising and updating procedures related to complaint handling functions

•Perform patient follow-up as it relates to product complaints

•Review complaint investigations (field/clinical service/quality engineering/quality assurance

reports, and component investigations)

•Support company-wide projects as required

Supervisor, Product Surveillance 11/2006-03/3008

IntraLase/AMO - Ophthalmology Irvine, CA

•Responsible for Global Complaint Handling Process, including Adverse Event reporting

•Responsible for providing guidance, leadership, oversight, and performance reviews of

direct reports

•Responsible for ensuring site compliance with FDA and European and Other International

Regulations

•Responsible for MDR/Vigilance determinations and filings in a timely manner to

appropriate agencies

•Supported multiple internal and external audits (Corporate, FDA, Notified Body)

•Supported CAPA, Document Control, Return Product and Quality Improvement project

activities

•Provided support to Technical/Customer/Field Services and Management as required

•Responsible for Complaint Trending and Chaired Monthly Complaint Meetings

•Responsible for Complaint Handling Training of new field/clinical service staff

•Responsible for revising and updating procedures related to complaint handling functions

•Performed patient follow-up as it relates to product complaints

•Reviewed complaint investigations (field/clinical service reports, and component

investigations)

•Served as Management Review Representative, presenting complaint updates to senior

management team

•Supported company-wide projects as required

Product Surveillance Specialist II 08/2005- 10/2006

IntraLase - Ophthalmology Irvine, CA

•Responsible for reviewing complaint file content from initiation to closure

•Responsible for MDR/Vigilance determinations and filings in a timely manner

•Supported FDA, Corporate and Notified Body inspections with zero observations

•Provided guidance as it relates to complaint handling to Technical/Customer/Field Service

Representatives

•Performed complaint trending & chair complaint meetings

•Supported document changes as it relates to complaint handling functions

•Performed complaint patient follow-up to support complaint files

Product Complaint Analyst 02/2004-07/2005

Interpore - Orthopedics Irvine, CA

•Performed Complaint Handling duties per FDA & International regulations

•Reviewed complaint information, follow-up information, customer communications, product

investigations

•Responsible for MDR/Vigilance/Baseline reporting

•Support FDA, Corporate and Notified Body inspections with zero observations

•Supported RA activities (Global Product Registrations, 510(k), data gathering)

•Supported training department for new hires/sales representatives in the area of complaint

handling

•Supported R&D, Quality, Marketing, Engineering projects (design inputs, labeling, and

related functions)

•Supported Document Control (ECO process, revising DMR, DHF, Technical files, labeling

review, etc…)

Product Complaint Facilitator/Supervisor 02/1997-12/2002

Mallinkcrodt/Tyco Healthcare - Respiratory Irvine, CA

•Responsible for Complaint Handling per FDA and International Regulations

•Generated and compiled MDR’s, MDVR’s

•Maintained Product Listings/Baseline Reports

•Coordinated Product Investigations for Complaint Handling & trained staff

•Processed product returns in support to complaint investigations- decontamination,

photographs, analysis (dimensional, functional, etc.)

•Performed device investigations, compiled reports and reviewed with management

•Managed internal and external communications (phone and customer feedback letters)

•Decreased complaint open file cycle times – streamlined process

•Implemented a new complaint tracking system – improved efficiency

•Implemented digital photography as part of streamlining investigation process

•Managed communications and interaction between Sales, Marketing, Customer Service, and

Technical Support (customer feedback, trending, C/A’s, Audit results, QIT)

•Performed company-wide Complaint Handling Training

•Supported Customer Relations as it pertained to complaint functions

•Assisted R&D with Clinical Research Studies - product testing, data collection & analysis

Lab Analyst 07/1993-01/1997

Mallinckrodt/Sorin - Respiratory Irvine, CA

•Monitored clean room compliance- RH/Air/Rodac/PM/Water testing

•Coordinated Environmental & Hygiene training for site employees

•Performed Water Microbial, Bio-Burden, gram staining, + general duties

•Chart Recording/Monitoring

Quality – Audit, Inspection, & Document Control 08/1988- 06/1993

Shiley/Pfizer - Cardiovascular Irvine, CA

•Performed Vendor, System, and Process Audits

•CAPA, RMR, CGMP, ISO, DHR, QIT, C/A’s

•In-process and Molding Inspection (JIT, batch inspection, bag & seal, 1 st piece, rework)

•Incoming Materials Inspection (shipping/product cartons, resin, chemicals, labels,

components)

•Assisted R&D with special projects (clinical research data collection, measurements,

testing)

•Back-up for Document Control in support of the ECO process (issue of new

document/part numbers, updating device master records (DMR), device history files

(DHF), Technical files, labeling review, maintenance of 510(k) files, product

sterilization lot release, etc…)

Education:

2005 Medical Product Development Certificate

UCI Extension, CA

2003 Bachelor of Science, Business Management

University of Phoenix, Fountain Valley, CA

Experienced with regulatory requirements: FDA/QSR/GMP/ISO/MEDDEV/STD’s

Proficient in MS Office, Excel, Access, Visio, PowerPoint, InfoMed, ComplaintMaster,

CATSWeb, PeopleSoft, SAP, report generation

Professional Development:

•RAPS/ASQ/OCRA/FDLI

•MDR Network Group

•Seminars: cGMP’s/Complaint Handling/Risk Management/Auditing/Customer

Service/Leadership

Interests:

•School PTA Member, Parishioner, Photography, Spend quality time with my children

References: Available Upon Request

Contact this candidate