Summary
Overview
Work History
Education
Timeline
Work Availability

Patricia Gomez

Medical Device Consultant
Oceanside,Ca.
The way to get started is to quit talking and begin doing.
Walt Disney

Summary

Over 25 years of Expertise in Biopharma and Medical Manufacturing throughout a variety positions. - Consultant, Clinical Coordinator, Quality Manager / Supervisor. When I was a Manager, I planned our production based on historical data of previous production rates and with Sales and Marketing forecasts. Currently Consulting at Canary Medical / Carlsbad, 14 years in Companion Diagnostics at Roche / Ventana Medical, Quality Manager at MDMI (Vancouver, Canada), a Sr. Supervisor at Medtronic (Santa Rosa, CA) and a Quality Assurance Inspector at Guidant (Temecula) I work great under pressure and consistently strive to ensure Internal and External Customer's needs are met in a timely and efficient manner. I work diligently with Planners and GSM, (Global Supply Management) to understand the requirements of our Patients’ needs. Great understanding of FDA guidelines and Regulations, ensuring that product gets released with all the necessary documentation and SAP transactions completed. . Goal-driven Consultant bringing in-depth knowledge of medical devices. Skilled in building connections with staff to cement professional relationships and maintain consistent revenue streams. Manages initiatives to keep leaders informed and optimize worker training. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Overview

28
28
years of professional experience

Work History

Medical Device Consultant

Canary Medical
Oceanside, CA
01.2023 - Current
  • Responsible and accountable to help all organizational team and function in succeeding in delivering design control specifications, technical transfer requirements, process optimization, complete product and process verification and validations
  • Executing to the proposed project plan by forward apprehension of technical factors and implementation of effective problem-solving methods
  • Quality and Regulatory Project Management in Class II & Class III medical environment

Clinical Sciences Project Coordinator

ROCHE/ Ventana Medical Systems, Inc
03.2007 - 11.2019
  • Coordinates assigned projects development and execution and maintaining project schedules and communication to stakeholders
  • Proactively responds to project schedule delays utilizing knowledge and judgment to determine the best corrective action to recommend to the project team and management
  • Facilities the preparation and review of deliverables for clinical and lab services projects, and the logistics of a harmonized sample process flow (between CSM, BSM, Histology, and Pathology)
  • Interfaces with laboratory personnel, quality control and the medical and scientific staff; coordinates data reporting
  • Compiles and summarizes data and generates standard and ad hoc reports as needed
  • Makes appropriate recommendations to management to improve process efficiency
  • Tracks identified activities relating to clinical study management projects and facilitates communication between various functional groups throughout the organization as required to expedite clinical study execution and project deliverables

Quality Assurance Technician

03.2005 - 12.2014
  • Ensure that all Reagent Teams needs are being met consistently and ensuring that product gets to finished goods in a timely manner, here in Tucson, Hungary, and outsourced vendors
  • This is accomplished by aligning with the Planner, Team Lead and co-workers to ensure that we consistently meet the needs of our customers
  • Cross trained on all Reagent Teams products or processes
  • Attended MRB to review NCR’s and helped with Investigations
  • Working knowledge of SAP and Agile.

Manufacturing Manager

MDMI
Richmond, Canada
10.2002 - 08.2004
  • Medical device manufacturing Start-up Company located in Richmond, BC; Canada
  • We had multiple production lines for different types of products
  • These product lines consisted of a thermal control unit, and disposable catheter for a thermal endometrial ablation device, a PTCA Catheter product line and a contract manufacturing line
  • I initiated all the necessary documentation to transfer the product from R&D into Manufacturing
  • I was able to retrieve necessary testing requirements from lab notebooks and initiated the specifications for the endometrial ablation device with very minimal assistance from R&D Engineers
  • Also worked with various international agencies including CSA, which is the equivalent of Underwriter's Laboratories.

Medtronic
Santa Rosa, Ca
07.1995 - 10.2001

Sr. Manufacturing Supervisor

AneuRx Division
05.1995 - 05.2000
  • Aneurysm Division
  • During my tenure in this Division, we had a recall and we had to re-structure our production area and re-validate our systems
  • I worked closely with QE / ME Engineering and revised 90% of our Manufacturing process instructions to ensure that we would be capable of passing an FDA audit
  • Once we were up and running, we managed to beat and exceed our production goals for 6 months straight
  • The yields went up significantly and the NCMR’s were reduced by 75%
  • Guidant - Temecula
  • Launched multiple Stent and Delivery System platforms into the commercial marketplace supporting the organization IPO creating a business market value of 800 million dollars
  • Each platform was completed in a 9-month timeline, design to market cycle
  • (MS11, GFX, GFX 2.5, GFX 2, S670, S660, OTW and RX delivery system
  • Also worked on the Clinical Evaluation line for the Ostial Stent, SVG Stent and delivery system, the Bifurcation Stent, and Delivery System
  • (AneuRx Division)
  • Worked on the Process and Equipment Development Team for Stent Manufacturing, Ballon Manufacturing and Delivery System and ensuring each process was integrated and completed with the required Validations.

Education

Business

Palomar College, Palomar, Ca

Timeline

Medical Device Consultant - Canary Medical
01.2023 - Current
Clinical Sciences Project Coordinator - ROCHE/ Ventana Medical Systems, Inc
03.2007 - 11.2019
Quality Assurance Technician -
03.2005 - 12.2014
Manufacturing Manager - MDMI
10.2002 - 08.2004
- Medtronic
07.1995 - 10.2001
Sr. Manufacturing Supervisor - AneuRx Division
05.1995 - 05.2000
Palomar College - , Business

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Patricia GomezMedical Device Consultant