Experience

INOVIO Pharmaceuticals, Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Vice President, Device Quality

  • Apr 2022 - Present



WitsEnd Consulting

• San Diego, CA

• President/Owner

  • May 2010 - Present

  Quality Consulting and QMS guidance Quality Consulting and QMS guidance



CTK Biotech, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• VP of Quality

  • Jun 2019 - Apr 2022



Metronom Health

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director of QA/RA

  • Jul 2018 - Apr 2019

  Establishing and implementing the initial Quality System (compliant with ISO 13485:2016 and FDA’s 21 CFR 820) and writing of FDA Pre-Submissions for a new disruptive technology for an integrated Continuous Glucose Monitor (iCGM) wearable device. Reason for leaving – company experienced significant delays in developing functional product and had a reduction in work force. Establishing and implementing the initial Quality System (compliant with ISO 13485:2016 and FDA’s 21 CFR 820) and writing of FDA Pre-Submissions for a new disruptive technology for an integrated Continuous Glucose Monitor (iCGM) wearable device. Reason for leaving – company experienced significant delays in developing functional product and had a reduction in work force.



Sommetrics

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director of Quality

  • Apr 2017 - Jun 2018

  Start-Up. Layoff due to loss of funding. Start-Up. Layoff due to loss of funding.



Mesa Biotech, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Director of Quality and Regulatory

  • Apr 2016 - Apr 2017

  Start-Up. Layoff due to loss of funding. Start-Up. Layoff due to loss of funding.



Sendx Medical, Inc.

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director - RA/QA

  • Aug 2012 - Oct 2014

  Directed, coordinated and dramatically improved the Regulatory Affairs and Quality System/Assurance activities for a Class II IVD Blood Gas Analyzer design and manufacturing facility. Managed successful FDA audit in 2014 with no 483 observations. Managed Quality Engineering, Quality Assurance, Quality Control, Document Control, and Regulatory Affairs. Served as Management Representative and primary FDA contact. Directed, coordinated and dramatically improved the Regulatory Affairs and Quality System/Assurance activities for a Class II IVD Blood Gas Analyzer design and manufacturing facility. Managed successful FDA audit in 2014 with no 483 observations. Managed Quality Engineering, Quality Assurance, Quality Control, Document Control, and Regulatory Affairs. Served as Management Representative and primary FDA contact.



Breathe Technologies, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director - QA/RA

  • Apr 2011 - Jun 2012

  Reviewed and improved the Quality System to comply with the FDA's QSR, and prepare for ISO 13485/CMDCAS/MDD certification, achieved in March of 2012. Recruit Quality staff to support the business relocation and growth. Support Design project to launch company's first product (achieved in November, 2011). Reviewed and improved the Quality System to comply with the FDA's QSR, and prepare for ISO 13485/CMDCAS/MDD certification, achieved in March of 2012. Recruit Quality staff to support the business relocation and growth. Support Design project to launch company's first product (achieved in November, 2011).



Astute Medical

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Head of Quality

  • Jun 2010 - Apr 2011

  Implemented a Quality System compliant to the FDA’s Quality System Regulation. Developed, validated and implemented Master Control (Document Control and Training) Implemented a Quality System compliant to the FDA’s Quality System Regulation. Developed, validated and implemented Master Control (Document Control and Training)



ResMed

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Director - QA/RA

  • May 2003 - Apr 2010

  As the Head of Quality for the Americas, established and coordinated all aspects of the Quality System, >70% of a $1 Billion global business of Class II medical devices for the treatment of obstructive sleep apnea. Developed strategic plans, recruited and developed the Quality Assurance/Control, Quality Engineering, Document Control, and Regulatory Affairs Departments in multiple locations. As the Head of Quality for the Americas, established and coordinated all aspects of the Quality System, >70% of a $1 Billion global business of Class II medical devices for the treatment of obstructive sleep apnea. Developed strategic plans, recruited and developed the Quality Assurance/Control, Quality Engineering, Document Control, and Regulatory Affairs Departments in multiple locations.



CR Bard / IMPRA

• Quality Systems Manager

  • Feb 2000 - Jan 2003

  Directed the Quality System on the design, manufacturing, and distribution on sterile implantable vascular grafts. Directed the Quality System on the design, manufacturing, and distribution on sterile implantable vascular grafts.



OrthoLogic

• Director - Quality Assurance

  • Apr 1994 - Aug 1999

  Developed and directed the Quality System within Class II Medical Devices (Bone Growth Stimulators and External Fixation Devices that were sterilized), design, manufacturing, distribution, and post surveillance. Developed and directed the Quality System within Class II Medical Devices (Bone Growth Stimulators and External Fixation Devices that were sterilized), design, manufacturing, distribution, and post surveillance.



Acoustic Imaging

• Phoenix, Arizona Area

• Quality Manager

  • Aug 1988 - Feb 1994

  Coordinated all aspects of the company’s Quality System and Test programs throughout the organization’s Diagnostic Ultrasound (510k) divisions, from start-up to $35mm in annual sales, establishing and administrating the program, coaching employees, and facilitating continuous improvement throughout the organization. Established strategic plans, policies, and procedures at all levels to ensure that requirements of FDA’s cGMP Quality Regulations were met. Managed 12+ individuals in QA, QC, Calibration and Test departments, as well as overseeing a $500K budget. Show less



ITT Courier Terminals

• United States
• Computer and Network Security
• 1 - 100 Employee

• Quality Engineer

  • 1977 - 1985