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Work Background
TekniPlexHead of Quality & Regulatory, MedTech Solutions (MTS)
Oct. 2025Ireland
MedtronicEngineering Program Director - Operations & Product Development
Aug. 2022 - Oct. 2025IrelandI'm a Product Development Core Team lead for Operations on Medtronic Development programs. This involves supporting new product development programs, NPI activities and acquisition integration work to ensure that there is a successful Manufacturing Strategy in place and planned execution. Key responsibilities include management of the following functions in line with the needs of the development program; Supply Chain Management, Supplier Quality, Process Validations, Packaging Validation's, Sterilization, Management of outsourcing programs and support for Clinical & early phase programs.
Self EmployedQuality & Operations Management Consultant
Mar. 2021 - Aug. 2022IrelandI provided Consultancy services to the manufacturing Industry. Specific areas of expertise include management of Quality Systems, Remediation Projects, Supplier Management, Quality Auditing, Interim Leadership, Quality Accreditation and Due Diligence Assessments.
Advanced Instruments, LLC.Director of Quality and Regulatory Affairs
Feb. 2018 - Feb. 2021Norwood, MassachusettsI was the Quality and Regulatory leader for the business and a member of the executive leadership team that was established to transform Advanced Instrument from a family owned company into a vibrant business that was a leader in the IVD market along with providing services and solutions to the Global Pharma industry. During this period I contributed to the P&L of the business by establishing Quality and Business processes that supported the rapid growth the business experienced. This included managing and implementing improvements in the following areas; Quality Management System, management of Contract Manufacturing partners, Supplier stabilization & Consolidation, Product Development processes, Customer Complaint Management and Risk Management Processes. I was directly involved in the preparation for a successful sale of the business in October 2021 and supported the due diligence activities leading up to the sale.
PhilipsSr Quality Manager
Oct. 2017 - Feb. 2018Andover, MassachusettsIn this role I was the Quality System Manager for Patient Monitoring business in North America. In addition to managing day-to-day aspects of the function, which included leading a quality team responsible for CAPA, Internal Audits, External Audits, NCMR's and Management Review, I was directly involved in supporting the business response to an FDA Consent Decree.
MedtronicSr. Quality Engineering Manager
Feb. 2008 - Sep. 2017Danvers MassachusettsOver the course of my tenure with Medtronic, I had the opportunity to work and support a number of key functions. These included: - Leading the Quality Systems organization for the Danvers Manufacturing facility during a period of growth and business transformation. - Leading the Supplier Quality Engineering function for the Brooklyn Park and Plymouth Manufacturing facilities. - I was directly involved in a number of high profile acquisitions in the Structural Heart business, that today contribute significantly to the overall success of the business. - I had the opportunity to both lead and support a number of enterprise wide improvement programs that shaped day to day operations by consolidating practices and aligning on core business needs. Specifically, Supply Management, Quality System processes and Risk Management.
Vysera BiomedicalHead of Quality and Regulatory Affairs
Jun. 2006 - Feb. 2008Galway
AccellentQuality Manager - Site Quality Lead
Nov. 2005 - Jul. 2006Galway
AerogenSite Quality Lead
Jun. 2004 - Nov. 2005Galway
Bio-medical Research LimitedProduct Engineer
Jan. 2001 - Jan. 2004
TycoEngineering Technician
Jan. 1999 - Jan. 2001
APC by Schneider ElectricEngineering Technician
Jan. 1995 - Jan. 1999
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