Product Development Quality System
Resume:
Thomas Furey
760-***-**** ad5tu7@r.postjobfree.com https://www.linkedin.com/in/tom-furey-a494b4/
OBJECTIVE
To provide technical leadership to an organization which can challenge my abilities and support career growth.
QUALIFICATIONS
Extensive knowledge of FDA QSR’s, cGMP’s, GLP, ISO/EN/MDD/ EU MDR requirements, Post Market Surveillance, interacting with regulatory agencies, initial product development to commercialization, FDA Design Controls, project planning, internal / external auditing, statistical tools, Start-up and Large Company experience, general validation principles, process validations (IQ, OQ, PQ) including sterilization validations (Steam, EtO and Radiation), cleaning studies, microbial testing, analytical testing, cleanroom design / qualification.
WORK HISTORY
Gener8, Carlsbad, CA
Medical Device Contract Design, Development and Manufacturing of
IVD microfluidic cartridges and plastic consumables
Sr. Quality Manager – 3/2021 to present
Lead all Quality activities and personnel while communicating a quality vision
Act as the Management Representative for ISO 13485 and ISO 9001 quality systems
Ensure effective CAPA management and reporting
Log, investigate and manage customer complaints. Recommend corrective actions.
Manage document control using Arena PLM quality management system
Ensure compliance to ISO, FDA, or other applicable regulatory changes
Member of the senior management team, provide input as it relates to the quality system
Identify opportunities to improve the quality system
Draft and maintain quality goals as the company expands into manufacturing
Manage site compliance to always ensure inspection readiness
Provide interface with client and vendor quality counterparts
Manage internal, external audits and customer complaints
Provide input to project schedules and budget
Participate in design reviews and risk analysis
MAST Biosurgery, San Diego, CA
Bio-resorbable adhesion barrier films, implants
Head of Quality – 07/2017 to 3/2021
Head of quality and regulatory for the company and Management Representative
Provided leadership to support, and sustain elements for company’s quality system both up-stream & downstream
Post Market Surveillance Planning and Reporting
Complaints MDR/Vigilance/CMDR and HHE/HRA
Key resource for ISO, EN, MDD, EU MDR and QSR requirements
Responsible for complaint, investigation, resolution and reporting both domestic and international
Maintaining Sterility Assurance program including validations and revalidations
Ensured compliance to internal, external procedures and requirements per regulations
Mentored junior employees within and outside the quality group
Spearheaded quality and cost savings improvements
Identified and supported quality / regulatory improvement activities
Supported regulatory filings both domestic and international
Responsible for managing external and internal auditing
Reports to the Chairman of the Board
Smith and Nephew, formerly ArthroCare Corp, bone anchors, PEEK, Stainless Steel, Titanium, Bio-resorbable PLA, stitching systems, knotless sutures, implants, Irvine, CA
Sr. Director of Quality Engineering – 10/2009 to 01/2017
Implement, support, and sustain elements of quality engineering and quality system
Procedure generation, training, auditing, and technical support
Key resource for ISO, EN, MDD, and QSR requirements
Responsible for complaint, investigation and trending.
Involved in FDA HHE/HRA events including product recalls.
Ensure compliance to internal and external procedures and requirements in new product development
Work with peer level management to ensure PDP plans are executed to support business objectives
Hire, manage, and train resources required to support quality engineering activities
Generate/approve process and design validation studies, capability studies, FMEA/Hazard analysis
Collaborate with engineering, manufacturing, and regulatory, and work with outside labs and suppliers
Support manufacturing operations OUS
Ensure that compliance to cGMP and EN/ISO 13485/MDD requirements are maintained
Reports to Senior Corporate, VP RA/QA/CA
USGI Medical, Endolumenal surgical system, obesity surgical system, implants, San Clemente, CA
QA/RA Director – 8/2008 to 10/2009
Obtained ISO 13485 certification
Design Dossier and Tech File
Post Market Surveillance Planning and Reporting
Complaints MDR/Vigilance/CMDR
Development and management of all quality systems and Management Representative
Implementing and ensuring compliance to FDA, ISO, EN, MDD regulations
Maintaining Sterility Assurance program including validations and revalidations
Managing document control
Corrective and preventive actions
Internal/external auditing
Preproduction quality, process validations
Quality training and quality engineering
Ablation Frontiers, RF ablation system for atrial fibrillation, RF ablation generator, catheters, Carlsbad, CA (Medtronic).
QA/RA Director – 1/2005 to 8/2008
Responsible for CE mark approvals for class 3 and class 2b devices.
Responsible for quality system certification to ISO 13485.
Post Market Surveillance Planning and Reporting
Complaints MDR/Vigilance/CMDR
Member of CEO’s senior staff and Management Representative
Support filing of IDE for RF ablation system.
Risk Assessment Document per ISO 14971-1, (Risk Analysis, FMEA).
Product safety testing, biocompatibility ISO 10993-1, IEC 60601-1.
Corrective, preventative action (CAPA), employee training.
Sampling plans, TQC methods, software development, validation, and control.
Defined DMR’s, DHR’s for disposable and non-disposable devices.
E-beam sterilization validations and process validations..
Utility, facility, process validations, IQ, OQ, PQ, Validation Master Plan.
EDUCATION
B.S. Biology, Arizona State University
PATENTS
United States Patent 7192436 - Pledget-handling system and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure
PROFESSIONAL ORGANIZATIONS
American Chemical Society, American Society for Quality Control, Toastmasters International
INSTRUMENT / COMPUTER SKILLS
AA, IR, UV/VIS, TGA, HPLC, GC, FTIR, DSC, Instron, electrical safety testing equipment, Windows, Word, Excel, Power Point, RF Flow, Visio, SAP, Agile Document Control (PLM), Arena eQMS (PLM).
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