Information Technology Quality Assurance Manager

• Mar 2023 - Present

Quality Manager

• May 2022 - Dec 2022

Quality Manager - Americas Division

• Oct 2018 - May 2022

Quality Manager

• Mar 2015 - Oct 2018

• Quality System Management for all aspects of Active Implantable Medical Device production, development, and regulatory compliance• Management Representative for EU Notified Body audits to AIMD & ISO 13485 for the purpose of renewal and maintenance of CE Certification• Hosted FDA inspections for compliance to 21 CFR Part 820 PMA implantable medical devices• Co-managed facility site transfer and obtained regulatory approvals from EU and FDA• Implemented numerous revisions to entire Quality Management System for ISO and CFR compliance• Responsible for setting priorities and delegating tasks to various personnel to ensure continued compliance to QMS regulations Show less

Sr. Quality Engineer

• Jun 2014 - Mar 2015

• Rewrote, implemented, and managed an entirely new CAPA system, compliant with 21 CFR Part 820 and ISO 13485• Revised Risk Management system to align with ISO 14971. Primary focus on FMEA and Hazard Analysis• Integrated Returns system into complaint system and performed Returned Product analysis• Led monthly Quality System status report meetings, set metrics and trending thresholds

Sr. Quality Engineer

• Oct 2007 - Jun 2014

• Certified ISO 13485 Lead Auditor, and have participated in FDA 21 CFR 820, ISO 13485, and Safety Agency IEC/EN/AAMI 60601 audits. • Instituted robust CAPA and NCMR system to improve quality system, and product nonconformance issue tracking. • Compile Risk Management File documentation including FMEA, Hazard Analysis, and Risk Assessments. • Complete Master Validation Plans, IQ/OQ/PQ/PPQ, and other various validation projects. • Arranged for agency safety testing to IEC/EN/UL/AAMI 60601-1 and collateral standards resulting in CB Scheme Certification and agency safety marking for Europe, US and Canada. • Wrote manufacturing safety test specifications and worked with manufacturing to develop test systems to ensure that all product meets or exceeds the minimum requirements for safety. • Work closely across many disciplines within the company, with suppliers and contract manufacturers, to improve manufacturing yields and product reliability in the field • Respond to problems arising from field issues, production yields, supplier changes, and other quality issues. Managed investigations and implemented corrective and preventive actions. Show less

Sr. Project Engineer

• Jul 2005 - Sep 2007

• Manage Lifecycle Projects for implementation of design changes to medical devices and systems including planning of document changes, verification, validation, qualification, system impact and process impact.• Review and approved verification, validation, and qualification plans and protocols.• Work closely across many disciplines within the company, with suppliers and contract manufacturers, to ensure projects were completed successfully and on time.• Respond to problems arising from field issues, production yields, supplier changes, and other quality issues. Managed investigations and implemented corrective and preventive actions.• Propose process changes to streamline change projects for increased speed and efficiency. Show less

Electrical Engineer

• Nov 2001 - Jun 2005

• Led product evaluation project for cardiac defibrillator during 1st full year in field to quickly determine root cause and prioritize issues based on risk in order to focus engineering efforts.• Led several formal medical product investigations to determine root cause of complicated system failures in cardiac defibrillators to implement effective corrective and preventive actions.• Made design changes to improve product performance and manufacturing yield.• Worked closely with vendors to improve component reliability and improve yield.• Worked with customers to improve relations and build confidence in company products.• Worked with an engineering team to develop a new Li+ battery charger and power management circuit. Show less

Continuation / Component Engineer

• Apr 2001 - Sep 2001

• Solved microprocessor-reset issue causing problems on all printed circuit assemblies. • Researched digital and analog component issues to save company over $100,000/year in procurement and manufacturing. • Helped design engineers source cutting edge electronic components including gigabit and 10gig Ethernet transceivers, microprocessors, network processors, and switch fabrics. • Solved microprocessor-reset issue causing problems on all printed circuit assemblies. • Researched digital and analog component issues to save company over $100,000/year in procurement and manufacturing. • Helped design engineers source cutting edge electronic components including gigabit and 10gig Ethernet transceivers, microprocessors, network processors, and switch fabrics.

Materials Engineer

• 2000 - 2001

• Helped design engineers source analog electronic components to ensure best possible price and availability for new designs. • Found and resolved many component procurement issues to avoid future reliability problems. • Updated design guide for electronic component selection. • Helped design engineers source analog electronic components to ensure best possible price and availability for new designs. • Found and resolved many component procurement issues to avoid future reliability problems. • Updated design guide for electronic component selection.

Computer Technician

• 1998 - 1998