Brian TARPEY
Galway
Summary
Highly motivated, innovative and organized engineering professional with substantial experience in QA/ DA and working in a highly regulated, fast-paced environment seeking to join a future-focused, multi-disciplinary team, and help support them in the development of new and exciting projects from start to finish that will have major positive impacts on customers, end-users, the organization, employees and both internal/external stakeholders.
Overview
5
5
years of professional experience
3
3
Certification
Work History
Design Assurance
Versono Medical
01.2025 - Current
- Responsible for compliance of product development and risk management activities with Versono Medical Policies and Procedures and applicable Governing Regulatory Requirements.
- Work effectively as part of product development team in identifying and translating user requirements into design requirements, identifying critical design features and components, and contributing towards or leading the generation of risk management documents and associated quality documents, reports etc .
- Complete design verification, design validation and test method validation activities associated with product development activities.
- Leads the resolution of project issues by working with team members, suppliers, and others as appropriate. Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
- Monitors compliance with Versono Medical policies, procedures and applicable regulatory requirements, identifying, reporting and implementing process and system improvements.
Quality Engineer
Versono Medical
01.2020 - 12.2024
- Responsible for compliance with Versono Policies and Procedures and applicable International Regulations.
- Leads and/or facilitates compliance and improvement activities associated with the Versono’s quality system (e.g. CAPA, audit programs, personnel training).
- Plan, execute, report and follow-up on quality system audits. Lead backroom activity during inspections and provide front room support as required.
- Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Monitor compliance with Versono’s policies, procedures and applicable regulatory requirements, identifying, reporting and implementing process and system improvements.
- Represent Versono professionally and positively externally to agencies, vendors, and regulators.
Education
MS - Medical Devices
Griffith College
Dublin09.2023
BE - Mechanical Engineering
National University of Ireland, Galway
Galway01.2019
Skills
- Problem Solving
- Communication
- Teamwork
- Microsoft Office
- CAD
- Fusion 360
- GitLab
- Power Apps
- Greenlight Guru
- SAI Global
Certification
- Advanced Risk Practitioner ISO 14971
- ISO 13485 Internal Auditor Training
- ISO 13485 Requirements Training
Hobbies & Interests
- Health and Fitness
- Martial Arts and Surfing
- Automotive
- Golf
- Design and Innovation
Timeline
Design Assurance
Versono Medical
01.2025 - Current
Quality Engineer
Versono Medical
01.2020 - 12.2024
MS - Medical Devices
Griffith College
BE - Mechanical Engineering
National University of Ireland, Galway