Mark Boyle

Mark Boyle Email and Phone Number

Head of Quality and Regulatory, MedTech Solutions (MTS) @ TekniPlex
County Donegal, Ireland
Mark Boyle's Location
Galway, County Galway, Ireland, Ireland
Mark Boyle's Contact Details
About Mark Boyle

Quality and Operations leader with experience building and managing successful teams. Degree in Technology Management from Sligo IT, Ireland and a Master of Business Administration (M.B.A.) from Endicott College, Boston, Massachusetts.

Mark Boyle's Current Company Details
TekniPlex

Tekniplex

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Head of Quality and Regulatory, MedTech Solutions (MTS)
County Donegal, Ireland
Website:
tekni-plex.com
Employees:
1919
Mark Boyle Work Experience Details
  • Tekniplex
    Head Of Quality And Regulatory, Medtech Solutions (Mts)
    Tekniplex
    County Donegal, Ireland
  • Medtronic
    Program Management - Operations & Product Development
    Medtronic Aug 2022 - Present
    Ireland
    I'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 Employed
    Quality & Operations Management Consultant
    Self Employed Mar 2021 - Aug 2022
    Ireland
    I 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
    Advanced Instruments, Llc. Feb 2018 - Feb 2021
    Norwood, Massachusetts
    I 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.
  • Philips
    Sr Quality Manager
    Philips Oct 2017 - Feb 2018
    Andover, Massachusetts
    In 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.
  • Medtronic
    Sr. Quality Engineering Manager
    Medtronic Feb 2008 - Sep 2017
    Danvers Massachusetts
    Over 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 Biomedical
    Head Of Quality And Regulatory Affairs
    Vysera Biomedical Jun 2006 - Feb 2008
    Galway
  • Accellent
    Quality Manager - Site Quality Lead
    Accellent Nov 2005 - Jul 2006
    Galway
  • Aerogen
    Site Quality Lead
    Aerogen Jun 2004 - Nov 2005
    Galway
  • Bio-Medical Research Limited
    Product Engineer
    Bio-Medical Research Limited 2001 - 2004
  • Tyco
    Engineering Technician
    Tyco 1999 - 2001
  • Apc By Schneider Electric
    Engineering Technician
    Apc By Schneider Electric 1995 - 1999

Mark Boyle Skills

Quality System Lean Manufacturing Spc Iso 13485 Fda Medical Devices Capa Validation Design Control Iso 14971 Design Of Experiments Minitab Dmaic Fmea Biomedical Engineering V&v R&d Design For Manufacturing U.s. Food And Drug Administration Research And Development Corrective And Preventive Action

Mark Boyle Education Details

Frequently Asked Questions about Mark Boyle

What company does Mark Boyle work for?

Mark Boyle works for Tekniplex

What is Mark Boyle's role at the current company?

Mark Boyle's current role is Head of Quality and Regulatory, MedTech Solutions (MTS).

What is Mark Boyle's email address?

Mark Boyle's email address is ma****@****ies.com

What schools did Mark Boyle attend?

Mark Boyle attended Endicott College, Institute Of Technology, Sligo.

What skills is Mark Boyle known for?

Mark Boyle has skills like Quality System, Lean Manufacturing, Spc, Iso 13485, Fda, Medical Devices, Capa, Validation, Design Control, Iso 14971, Design Of Experiments, Minitab.

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