Medical Device Quality Control

Vanessa A. Velez

*** ********* *****, ********* ** 94565 ■ Home: 925-***-**** ■ Email: ***********@*****.***

Objective

To obtain a position as an assistant histology technician in a reputed lab.

Qualifications:

Sound knowledge of the principles and practices of histological techniques. Solid working experience with

histology laboratory equipment. Knowledge running single, double and triple IHC assay’s, RISH, CISH,

and Fluorescence. Grossing and fixing tissue samples. Preparing and embedding of tissue sections.

Sectioning of parrifin embedded blocks. Assisting in the QC laboratory as well as the validation and

verification department. Technician in the R&D department.

Administrative/Technical support professional. Experienced working in fast paced environments

demanding strong analytical, organizational, technical and interpersonal skills. Detail orientated.

Experience

Biocare Medical LLC- Concord, CA 2007-Present

Mircotomy, QC, Validation and Verification and R&D

• Duties include processing, embedding, cutting paraffin embedded tissue. Principle of H&E

staining, Immunohistochemistry, RISH, Fluorescence and In-situ. Assistant to the histology

department. Thorough knowledge of proper tissue fixation and staining of histologic sections.

Basic knowledge of budgetary procedures and ordering supplies and equipment. Ability to plan,

organize and supervises work schedules of subordinates. Concept of fixation, gross sectioning,

collection of tissue specimens, filing of slides and blocks, running tissue processor, decalcification

of bone and hard tissue, coverslipping.

• Backed up the QC department. Performed Quality Control Testing on Stainers manufactured and

reconditioned in house. Performed 24 hour burn-in’s on all stainers. Completed all necessary

documentation required for the Quality Control process. Performed verification and validation of

stainer software. Followed protocols and QS procedures. Tracked lab procedural paperwork, QC

req and documentation knowledge. Performed routine Product Surveillance testing of the

products

• Assistant to the Validation and Verification department. Validation for IHC instrumentation as well

as IHC/RISH reagents. Monitored equipment and instrumentation for compliance to corporate

procedures.

• Assisted in the research and development department for 2 years. R&D tested a range of high

quality products for IHC/ICC experiments. Biocare’s primary antibodies are manufactured under

controlled conditions to ensure lot-to-lot consistency, high specificity, and outstanding

performance. Assisted with Development of new products. Followed ISO and departmental

procedures. Performed basic testing on pre-established products to maximize the quality and

stability of the products. Performed research testing for new products where the protocol has

been pre-determined by the V.P. of Immunohistochemistry or Director of R & D. Receipt and

maintenance of incoming raw material related to the research of the product. Documents all

activities associated with the design and development of new products or processes. Monitor

equipment and instrumentation for compliance to corporate procedures. Assists in laboratory

maintenance activities / procedures.

• Assisted in the technical support department for one year. Provided support to our customers on

entire companies product line. Antibodies, Detection, Reagents.

Tyco Healthcare – Respiratory Division, Pleasanton, CA 2004-2007

Technical services assistant.

• Provided initial point of service for customer complaints for the respiratory division

• Provided Tier I level technical support for pulse oximetry, capnography, airway products and

telemetry devices families. Used product knowledge to ascertain relevant failure information

• Maintained compliance with all pertinent regulations and standards. Assisted in determining root

cause when possible.

• Interfaced with various internal and external entities such as Technical Services and Product

Monitoring/Post Market Surveillance to assist with obtaining complete information or product

complaint analyses.

• Maintained records (hard copy, soft copy, etc) relative to product returns.

• Analyzed product complaints-trends-call volume and root cause of complaint/failures.

• Audit daily reports.

• Maintained records on returns/credits/and failure investigation on FDA recalled product.

Varian, Inc., Walnut Creek CA 1999-2004

Lead service representative

• Processed, acknowledged, invoiced and kept monthly reports on all telephoned, faxed, emailed

and online orders for Varian’s Chromatography product line.

• Managed selected multi-million dollar consumable accounts with a one-on-one business

relationship with clients.

• Only representative that oversaw internationals special HPLC custom columns specifications and

ordering for gas chromatography. Lead for Drugs of Abuse line: One of two selected to lead and

manage newly acquired line from Roche. Trained, marketed and analyzed monthly sales and

trends for this product. Created, oversaw and issued all government contracts for this product.

Traveled and trained new clientele. Provided prompt efficient knowledgeable service.

Sales/Customer Support

• Managed customer orders from entry to shipment and responsible for ensuring accuracy of

customer purchase orders including products, pricing, terms, delivery requirements and tax

certificates

• Interfaced with all appropriate departments to address customer issues, including proactive

backlog review, expedited/delivery, and shipping and routing issues.

• Endured export compliance, including licensing and screening.

• Provided support for 135 engineers, from routine maintenance to custom solutions for unique

applications. Reviewed and administered commercial service agreements. Manage and deploy

service test equipment and inventory. Coordinate service related accounts receivables.

• SAP experience, Microsoft Office Program and experience with technical databases

• Experienced working directly with customers and demonstrated experience as a customer

advocate.

• 3 years of experience in a medical device environment for Class II products.

• Working knowledge of QSR, ISO 13485, MDD and CMDAS requirements for medical device

complaint handling.

• Strong written and oral communication skills; ability to work independently and interact with

management.

Education

California State University, Hayward, Hayward CA 1995-1999

Los Medanos College, Pittsburg, CA 2004-2005

Biocare Medical LLC- On the job training Present

NSH credited courses

References upon request

Contact this candidate