Experience

BioTrace Medical Inc.
• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee
• Director, Head of Quality, CMQ/OE, Management Rep.

  • Jan 2018 - Present


VytronUS, Inc.

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

• Quality System Manager

  • Jul 2016 - Jan 2018

  Quality system manager in an ISO 13485:2003 quality system with ongoing enhancements toward 2016 compliance requirements; gap analysis, SOP revisions, and implementation. Operating to the requirements of FDA’s QSR (Quality System Requirements) 21 CFR Part 820. Supplier Management related to evaluation, supplier audit, qualification, quality agreements, and SCAR (corrective action). Reduction of administrative burden for low risk suppliers, while improving organizational compliance and communications for key supplier/partners. Responsible for prioritization and management of all incoming quality inspection, receiving, sustaining quality engineering, and design assurance. Integrated role as an individual contributor, as well as Manager, working in conjunction with cross functional teams comprised of R&D, Manufacturing Engineering, Regulatory Affairs, and Clinical. Design assurance activities to bring novel technologies to market under aggressive timelines. Sustaining and developmental work for equipment identification, qualification (IQ/OQ), preventive maintenance, calibration, as well as non-product software validation for systemic control. Design transfer activities to ensure the device requirements are properly translated into production, including process validations (OQ/PQ/PPQ), manufacturing/quality process instructions, as well as authoring and executing Protocols/Reports in collaboration with supporting area subject matter experts.



Avinger Inc. (Acquired Sawooth Labs)

• Manager, Quality Assurance Engineering

  • May 2011 - Jul 2016

  Duties include the planning, scheduling, and completion of quality engineering projects in a manner consistent with organizational objectives and quality/regulatory requirements. Responsible for the successful and timely completion of individual projects as well as the projects of subordinates providing quality engineering leadership and support for mechanical, electrical, and software product development and design change efforts, in a fast paced, performance dependent, high energy start-up environment.



Medtronic Spine & Biologics

• Medical Device
• 100 - 200 Employee

• Principal Quality Engineer, New Product Development

  • Aug 2006 - May 2011

  New product development projects providing quality engineering support, examples of key deliverables include: product performance analysis, risk analysis, essential requirements, design verification / validation, design transfer, design requirements, and product release authorization for distribution of product. Ensure engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations, including engineering drawings/specifications in accordance with GMP and FDA guidance.



Abbott Diabetes Care

• Sr. Supplier Quality Engineer / Supply Base Mgr.

  • Aug 2002 - Jan 2007

  International supplier tooling and manufacturing process validation. Supplier audit and qualification. New product development core team support. Design for manufacturing enhancements. Cost reduction. International supplier tooling and manufacturing process validation. Supplier audit and qualification. New product development core team support. Design for manufacturing enhancements. Cost reduction.


Guidant
• United States
• Law Practice
• 1 - 100 Employee
• Supplier Quality Engineer

  • Aug 1998 - Aug 2002