CV

Professional Summary

Strategic leader in advancing medical technology, specializing in quality assurance, operations and regulatory compliance for medical devices. Proven track record in developing and implementing robust quality management systems (QMS) that meet FDA regulations (21 CFR 820) and ISO standards (ISO 13485, 14971). Experienced in leading global quality operations, design and development, site and product certification attainment, and integrating quality into business strategies. Skilled in leveraging AI and ML to enhance quality processes. Extensive experience in regulatory inspections (FDA & Notified Body), risk management, and supplier quality management. Committed to delivering safe and effective products through innovation and rigorous quality standards.

Achievements

• Recipient of Werfen Leadership & Management Excellence Award.
• Recognition Award: Leadership for transforming the Memphis Global Operation Center and promoting excellence.
• Recipient of NuVasive Cheetah Quarterly Award (EMEA).
• Finalist in Universitas 21, a competition between leading global universities.
• Selected as university representative for PwC Innovation Challenge.
• Recipient of Newstalk MBA bursary for MBA at UCD Michael Smurfit Business School.

Education

• Executive Leadership Program, University of Oxford, Saïd Business School
  • Modules inc: Leading with Power and Influence, Mastering Complexity and Polarity, Leading for High Performance
• Executive MBA, University College Dublin
  • Haas School of Business, Berkeley — Exchange Program: Leadership in the 21st Century
  • IE Business School — Exchange Program: High Tech Entrepreneurship
  • Capstone: Partnered with a consulting firm with annual revenues in excess of a billion, to develop a growth strategy for the firm’s supply chain services lines.
• MSc, Biomedical Engineering, University of Galway
  • Thesis: Addressing a clinical need for Stress Urinary Incontinence, as identified by BioInnovate.
• BEng, Biomedical Engineering, University of Limerick
  • Final Year Project: Investigation of hemodynamic factors and their effect on Aneurysm formation.

Career Experience

• Werfen, Leader in Specialised Diagnostics Systems (Sept 2024–Present)
  • Senior Director Quality Assurance · Hemostasis and Acute Care Division
    • Oversaw China Localization initiative, involved transferring manufacturing locally with fast-track process NMPA Audit.
  • Director, Quality Systems, Engineering, Document Control & Risk Management · Hemostasis and Acute Care Division
    • Role expanded to include Document Control in Oct 2025, comprising change control, ERP Management & Website.
    • Role expanded to include Risk Management in Apr 2025, comprising cyber, software, usability, design and process.
  • Director, Quality Systems & Engineering · Hemostasis and Acute Care Division
    • Coordinated QA activities for a $50 million investment in a 169,500-square-foot R&D facility expansion.
    • Oversaw China Localization initiative, involved transferring manufacturing locally with fast-track process NMPA Audit.
• Globus Medical, Leader in Musculoskeletal Solutions (Jan 2020–Sept 2024)
  • Director Quality, Branch Medical Group & Specialized Orthopedics · Manufacturing Class I, II & III Medical Devices
    • Initiated global initiatives: Quality at the Source, AI & ML Utilization, Metrology Forecasting Models.
    • Led cross-functional teams to manage the remediation of design controls for FDA submittal.
  • Director Quality, Branch Medical Group · Manufacturing Class I & II Medical Devices
    • Led 23 consecutive external competent authority, state and regulatory agency audits with zero non-conformities.
    • Ensured alignment of QA financial planning with business strategy, supporting efficient resource allocation.
  • Senior Manager Quality, Global · Responsible for Global Quality Operations
    • Improved CAPA on-time completion rates from 0% (2022) to 95% (2023), ensuring timely resolution of quality issues.
    • Managed the reduction in receiving inspection daily backlog from 3,600 lots (P95 100 days) to 180 lots (P95 2 days).
    • Overtime reduction of 35%, headcount reduction of 20%, while insourcing inspection.
  • Senior Manager Quality, International · EMEA, APAC & LATAM, 17 Operations Sites
    • Guided a high-performance global quality team across 5 continents through various transformational projects.
    • Quality lead for Market Access Program, a program used to assess and execute market entry strategy.
  • Quality Manager, International · EMEA, APAC & LATAM, 16 Operations Sites
    • Led CAPA on-time completion rate improvement from 56% to 98% across EMEA, APAC & LATAM region.
    • Led the expansion of capabilities on an ISO certified site, servicing and installation of integrated technology platform.
    • Ensured European launch of a Robotics System, liaised with the Notified Body to ensure regulatory compliance.
  • Quality Manager, EMEA · 5 Operations Sites
    • Led work streams in both operational and quality initiatives, examples include MDR (2017/745) compliance.
    • Responsible for development and setup of a Quality Management System in 5 sites across Europe.
    • Led attainment of ISO 13485 certification at International Head Quarters.
• Integer Holdings, Leader in Advanced Medical Device Outsourcing (Dec 2016–Dec 2019)
  Senior Quality Engineer, Corporate · Reporting to VP, Leading Quality Initiatives in Cardiovascular Division
  • Responsible for standardising processes across 7 manufacturing sites, including risk management (ISO 14971).
  • Developed a process control assessment system to identify compliance gaps to regulatory standards in a site’s quality management system. Summarised findings in a report for executive level review.
  • Led design risk management remediation projects, enhancing product safety and compliance across 4 sites.
  • Coached site managers and cross-functional staff through more than 50 CAPAs.
• Stryker (Jan 2016–Jan 2017)
  • Senior Advanced Quality Engineer · New Product Introduction SME for multiple sites
    • Quality lead for the validation activities of a new on-site metallurgical testing facility for implantable additive devices.
    • Responsible for evaluating the Design History File of implantable devices (Annual Revenue of approx. €500 million).
    • European rep on the corporate cross-functional team for the creation of a design to manufacturing risk procedure.
  • Advanced Quality Engineer
    • Directed change control activities with cross-functional supplier team for a resin change for a moulded component.
    • Quality lead on inspection alignment project, for internal and supplier inspection processes.
• Sanmina, Original Equipment Manufacturer of Electronic Class II & III Medical Devices (Jul 2014–Jan 2016)
  • New Product Introduction Quality Engineer · Quality NPI Coordinator
    • Quality lead for new electronic product introductions, responsible for developing process controls.
    • Customer facing site rep for quality related queries and performance measures (including cost).
  • Quality Engineer
    • Managed the day-to-day running of production lines, including monitoring non-conformance reports.
    • Collaborated with the customer design team to ensure effective design for manufacturability.
• TE Connectivity (May 2011–Jan 2012)
  Design Service Engineer, New Product Introduction
  • Conducted validations on critical-to-quality attributes for components of a laparoscopic surgery set.

Certifications & Training

• AI/ML & Analytics:
  • Machine Learning Engineering for Production (MLOps) Specialization – DeepLearning.AI
  • Introduction to Machine Learning in Production
  • Natural Language Processing with Probabilistic Models – DeepLearning.AI
  • Natural Language Processing with Classification and Vector Spaces – DeepLearning.AI
  • Data Analytics in Business – Georgia Tech Professional Education
  • Analytics Modelling – Georgia Tech Professional Education
  • Advanced Learning Algorithms – Stanford Online/DeepLearning.AI
  • Machine Learning – Stanford Online
• Quality & Regulatory:
  • Root Cause Analysis – American Society for Quality
  • Managing FDA Inspection for Pharmaceutical Manufacturers – Stryker Internal
  • Systems Based Drug Inspection – Stryker Internal
  • Internal Quality Management System Auditor – Irish Quality Centre
  • Process Validation – Irish Medical Devices Association
  • Risk Management for Medical Device Design – Stryker Internal
  • FDA Audit Training – Sanmina Internal
  • IPC-A-610 Acceptability of Electronic Assemblies – Institute of Printed Circuits
  • Design and Interpretation of Clinical Trials – Johns Hopkins University
• Operational Excellence:
  • Lean Six Sigma Green, Yellow, White Belt Certifications – Sanmina Internal
  • Design of Experiments with Minitab – Irish Medical Devices Association
  • Statistics in Minitab – Irish Medical Devices Association
  • Project Management & Lean and Six Sigma – National University of Ireland, Galway
  • Advanced Skills for Advanced Materials – nw texnet
• Business & Leadership:
  • European Business Law: Competing in Europe – LUND University
  • European Business Law: Doing Business in Europe – LUND University
  • European Business Law: Understanding the Fundamentals – LUND University
  • Effective Business Presentations – PricewaterhouseCoopers
  • Mentored by PwC Academy Director, as winner of Universitas 21
  • Problem Solving with Excel – PricewaterhouseCoopers
  • Data-driven Decision Making – PricewaterhouseCoopers
  • Influencing People without Authority – Stryker Internal

Volunteer & Project Work

• Kiva — Enhance financial inclusion by crowdfunding loans, offering capital to underserved communities and removing barriers to financial access worldwide.
• Racial Equality Task Force — Part of the team at NuVasive tasked with conducting a review and ranking of diversity and inclusion projects.
• Irish Medtech Association (Ibec) — Facilitating in the development of a commercial excellence model for the Irish MedTech Industry.
• Accessible Mojo — Conducted a market feasibility analysis for an independent, global rating system for hotel accessibility.
• Steth.ai — Facilitated the successful application for government-run funding for democratizing heart sound diagnostics.
• Thula — Developed a market entry strategy for a pharmaceuticals sourcing system for a start-up.
• Tulsa — Aiding in the care of foster children, intermittent work with a state agency responsible for improving wellbeing and outcomes for children.