BAYER DIABETES

QUALITY ENGINEER
WILSONVILLE, OR
OCTOBER 2012-MAY 2013

• Aided in IDE for Class III Continuous Glucose Monitoring System

• Developed quality system procedures complaint to ISO 13485 and FDA.

SONIVATE

QUALITY ENGINEER
BEAVERTON, OR
JULY 2012 - OCTOBER 2012

• Developed a complete quality system per ISO 13485

ST. JUDE MEDICAL

EXTERNAL QUALITY ENGINEER
PORTLAND, OR
OCTOBER 2011 - MARCH 2012

• Provided oversight of the corrective action process

• Developed and implemented appropriate improvements to drive product and process improvement to ensure compliance in a regulated industry.

• Provided independent, objective assurance and advisory services designed to add value, and minimize risk.

• Ensured the effectiveness of the Quality System by developing and implementing intuitive processes and assuring consistency in identifying, investigating, reporting, measuring, and responding to compliance issues through development and implementation of consistent tools, training programs, and actionable metrics.

• Remediated Process validation for IQ, OQ and PQ’s

TYCO ELECTRONICS

REGULATORY AND QUALITY PROJECT MANAGER
WILSONVILLE, OR
JANUARY 2010 - SEPTEMBER 2011

• CAPA Quality System Corporate Quality Systems process owner for the global corrective and preventive action process.

• Monitored investigations and approvals to ensure that all the required

• Facilitated weekly Corporate Corrective Action Board (CAB) meetings.

• Developed effective Corporate CAB presentations and maintain meeting minutes.

• Facilitated discussions with CAPA owners to drive completion of investigations, root-cause analysis, impact analysis, and closure of events.

• Analyzed trends to monitor the effectiveness of the CAPA process and drive remediation for improvement.

• Escalated issues to senior management in a timely manner ensuring information is captured and documented with relation to events.

• Provided training and system awareness on a global level.

• Expertise in cGMP FDA and ISO audits

• Aided in 510k submission for ECG monitoring system including strategy, technical consulting on validation and labeling

• Provided in-depth knowledge as a quality systems specialist for cGMP and ISO 13485 corporate guidelines and procedures to meet FDA, EU and Canadian Regulatory requirements

• Certified Internal Quality Auditor; Performed internal audits

• Devised statistical process control validation sampling plan process for process used in cable production e.g., molding, crimping, etc.)

BIOMÉRIEUX, INC.

QUALITY ENGINEER
WILSONVILLE, OR
MAY 2009 - JANUARY 2010

• Coordinated and Facilitated the Corrective and Preventive Action Program

• Facilitated Corrective Action Review Board Meetings with presentation and meetings minutes

• Managed CAPA owners to drive completion of investigations, root-cause analysis, impact analysis, and closure of events.

• Analyzed trends to monitor the effectiveness of the CAPA process

• Escalated issues to senior management in a timely manner. (Field Safety Action Committee)

• Monitored investigations and approvals to ensure that all the required information is captured and documented with relation to events.

• Reported monthly quality metrics and data analysis including bi-annual management reviews

• Complaints handling, investigational analysis and trending utilizing Trackwise Quality System program

• Reviewed and approved of product and process protocols and validations for engineering processes for in-vitro diagnostics

• Developed Risk Management files for new product introduction

• Integrated Quality System for cGMP and ISO 13485 with corporate guidelines

• Served as auditing interface with external agencies and internal auditing experience

HEMCON MEDICAL TECHNOLOGIES, INC.

QUALITY ENGINEER
PORTLAND, OR
JUNE 2005 - OCTOBER 2008

• Organized, coordinated, prepared and facilitated the preparation and approval of US Submissions FDA (Premarket submissions such as Investigational Device Exemptions (IDE), 510(k), Canadian licenses and European submissions in compliance with the Medical Device Direction (MDD for Class III hemostatic devices)).

• Obtained ISO 13485 (including Canada) certifications by developing the quality system (SOPs and training) from both a quality and regulatory standpoint to comply with the regulations/standards.

• Interfaced during audits and submission discussions with governmental agencies (e.g., Notified Bodies and the Food and Drug Administration (FDA)) regarding regulatory issues.

• Helped to prepare/write US Army grant regarding regulatory strategy and quality objectives/governing regulations for development of a lyophilized (freeze-dried) human plasma product (biologic).

• Validated SIP/steam generator for new lyophilization system IQ/OQ/PQ

• Aided in physically validating a lyophilization system

• Wrote and performed a protocol/report (PV) for process validation of a new hemostatic product

• Analyzed quality system data for quality metrics and year-end management review.

• Developed validation and operation test plans and directed execution for equipment used in the analysis,

qualification and in vitro release testing of medical devices.

• Served as quality and regulatory over-sight on new product development design teams.

• Submitted all regulatory applications electronically

BIOTRONIK, INC.

REGULATORY AFFAIRS COORDINATOR
LAKE OSWEGO, OR
OCTOBER 1998 - JUNE 2005

• Organized, coordinated and prepared Premarket Application submissions (PMA, 510(k), PMA supplements) relating to commercially distributed pacemaker and defibrillator devices, programmers and leads.

• Served as project leader for submission of advanced heart failure devices (biventricular pacing systems). Prepared original PMA for biventricular ICD.

• Served as project leader for a novel, legally marketed pacemaker that bases heart rate on emotion and stress in addition to conventional motion-based rate adaption.

• In conjunction with Clinical Research, prepared and directed the generation of Investigational Device Exemptions (IDEs) for conducting clinical investigations in the U.S.

• Generated the required submissions (progress reports, etc.) to support the continuation of clinical studies. Manufacturing changes and supplements.

• Supported engineering new product development introduction teams to ensure that regulatory requirements and standards were incorporated in the product development process and product design.

• Reviewed and provided input to labeling and marketing programs in reference to regulatory requirements, including writing product technical manuals.

• Maintained abreast of current technical literature (clinical journals, press releases and the Code of Federal Regulations (CFR) pertinent regulations, laws and industry developments; advise senior management as necessary).

• Interfaced with regulatory agency representatives (FDA in face-to-face meetings and phone negotiations) as needed to accomplish the above tasks, such as real time reviews.

• Electronically submitted all premarket applications.

ALLERGAN, INC.

REGULATORY AFFAIRS ANALYST
IRVINE, CA
JULY 1997 – SEPT. 1998

• Prepared and submitted/filed regulatory applications relating to phacoemulsification (cataract surgery) systems and accessory products in various international countries including Europe, Japan, Australia and Canada.

• Gained comprehensive knowledge of the European Medical Device Directive (MDD), as well as international devices registration regulations and requirements.

• Prepared CE Mark dossiers based on the MDD requirements (risk assessments, essential requirement checklists, clinical reports establishing safety and effectiveness).

• Served as liaison with test houses (TϋV) providing technical information and data to obtain type test approval to meet requirements of the MDD CE Mark and satisfy functional safety standards.

• Achieved comprehensive knowledge of 21 CFR 800 – U.S. federal regulations regarding medical devices.

MEDICAL DATA ELECTRONICS

SOFTWARE VALIDATION/CLINICAL ENGINEER
ARLETA, CA
FEBRUARY 1995-JUNE 1997

• Validated and verified software for portable patient monitoring systems that included ECG, respiration, CO2, cardiacoutput, blood pressure, and temperature.

• QP3
• Livelink
• Trackwise
• ETQ (Quality System Management Software systems) 
• ADAPT (pharmacokinetics modeling program) 
• Genesis (neurophysiologic modeling program)
• FORTRAN 77

• MatLab
• MathCad
• Adobe Creative Suite
• Microsoft Project
• Microsoft Office

UNIVERSITY OF SOUTHERN CALIFORNIA

LOS ANGLES, CA
B.S. MECHNANICAL ENGINEERING
B.S. ENGINEERNG SCIENCE - BIOENGINEERING
1993-1995

• Teaching assistant for biomedical engineering and physiology courses
• Master’s Thesis: “Kinetic Modeling of AMPA and NMDA receptors in Long-Term Potentiation (LTP) in the Brain”

UNIVERSITY OF MICHIGAN

ANN ARBOR, MI
M.S. BIOMEDICAL ENGINEERING
1989 - 1993

• Extracorporeal Membrane Oxygenation Laboratory
• SARNs 3M Senior Intern