Quality Management
Resume:
Gordon Smith **** Sandhurst Way
Rocklin, CA *****
**********@*****.***
CAREER OBJECTIVE: To be part of a team that continually strives to improve product quality and service to
achieve desired customer satisfaction and objectives.
EXPERIENCE:
Quality Management Regulatory Compliance Additional Skills
Supplier Qualification 21 CFR Part 820 SOI/SOP Management
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CAPA / MRB / Document Control ISO 13485:2003 Forms / Template Design
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Sterilization & Packaging
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IVDD, MDD Directives MS Office Applications
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Validation
Electrical Safety / EMC
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IQ/OQ/PQ Validation Process Computer Proficient
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Compliance
ISO/QSR Lead Auditor Health Canada QSR & CMDCAS
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DFT, Lean MFG, Kaizen MedWatch & Vigilance Reporting
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Biocompatibility – ISO 10993
Inspection & Test
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Labeling Design and Inspection
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Legalization & Authentication
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Control
Risk Management / dFMEA &
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Certificate to Foreign Gov.
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pFMEA
WORK HISTORY:
Synvasive Technology, Inc. El Dorado Hills, CA – Jun 2008 to Feb 2013 – Quality Manager
Managed quality system compliance for devices in Orthopaedic Surgery.
- Maintained all FDA, EC, and Canada regulatory requirements [i.e. official correspondent, device listing and
registration, technical files, CFG, DHHS,].
- Managed sterile device activities under ISO 7 class 10,000 CEA.
- Created validation procedures for GAMMA and EtO process in accordance with ISO 11137-1 and ISO 11135-1.
- Implemented risk management system using dFMEA and foreseeable risk templates that streamlined activities.
- Managed sterile device packaging qualifications according to ISO 11607.
- Managed expansion division in Reno, NV; achieved FDA, ISO 13485, and CMDCAS registration.
- Received CE Certification for Orthopaedic Prosthesis Implantation Instruments family of products.
NAI Tech Products, Inc: Auburn, CA – Dec 2003 to Jun 2008 – Manager, RA/QA
Managed quality system compliance for devices that store and process DICOM Imaging Modality.
- Successfully passed a FDA audit with no nonconformities [Aug. 2005]. Achieved the highest supplier rating
given by GE-Healthcare for supplier QMS [Mar. 2006].
- Managed second division in Camarillo, CA and achieved upgrade registration to ISO 13485:2003.
- Brought two divisions into compliance with Health Canada and Europe.
- Maintained all FDA and US regulatory requirements.
- Managed Document Control Department to streamline ECN/DCN process and improve throughput.
Dade Behring Inc: West Sacramento, CA – May 2000 to Dec 2003 – Manager, Quality Control
Managed QA Department for IVDD devices that test Microorganism Susceptibility and Blood.
- QA compliance included system software validation, inspection & test, MRB, CAPA, SOP/SOI management,
first article qualification.
- Facilitated supplier management program; selection, audits, dock-to-stock, and continuous improvement.
- Code Compliance Coordinator for IVDD Instruments – Electrical Safety and EMC certification for “CE” mark.
ADAC Laboratories: Milpitas, CA – March 1999 to May 2000 – Sr. Quality Systems Engineer
Processed complaints for devices used in Nuclear Medicine and RTP.
- W ork with cross functional groups to determine root cause and corrective action.
- Created MedWatch reports on FDA reportable events.
- Chair a Complaint Resolution Board that analyzes product trends and severity assessment of complaints.
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Participated in a task force that processed (81) retrospective MDR’s for filing with the FDA.
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- Field Advisory and Product Recall Coordinator.
Artesyn Technologies: Fremont, CA - August 1997 to March 1999
Quality Engineer for national accounts (3Com, Motorola, DSC, etc.) – Power Industry.
- W orked on teams that performed design verification to qualify new, standard, and modified products.
- Investigate root cause and provide customers with corrective action to product failures.
- Generate monthly reports for DPPM, MTBF, and factory/field reliability.
Laserscope: San Jose, CA - October 1994 to August 1997
Quality Engineer - Medical Lasers
- System Administrator for complaint handling system [EasyTrack].
- Prepare and maintain medical devices for European Standards, UL & EU Classifications.
- Generate SOP's for the process of ISO 9000 and FDA requirements of GMP's.
- Technical File creation for CE mark certificate.
- Develop and maintain supplier qualification system using core team approach.
Continuum: Santa Clara, CA - August 1989 to October 1993
Quality Engineer - Scientific Lasers
Northern Telecom Inc: Santa Clara, CA – September 1982 to August 1989
Sr. Mechanical Inspector – Telecommunication PBX
EDUCATION: AA Degree in Quality Assurance - 6/92, DeAnza College. Cupertino, CA
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