Helen Macmahon

Helen Macmahon Email and Phone Number

Moderator for Project Management @ Centre for Project Management - University of Limerick
Ireland
Helen Macmahon's Location
Ireland, Ireland
Helen Macmahon's Contact Details

Helen Macmahon work email

Helen Macmahon personal email

n/a
About Helen Macmahon

Helen Macmahon is a Moderator for Project Management at Centre for Project Management - University of Limerick. She possess expertise in design control, quality assurance, life sciences, quality system, medical devices and 18 more skills.

Helen Macmahon's Current Company Details
Centre for Project Management - University of Limerick

Centre For Project Management - University Of Limerick

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Moderator for Project Management
Ireland
Helen Macmahon Work Experience Details
  • Centre For Project Management - University Of Limerick
    Moderator For Project Management
    Centre For Project Management - University Of Limerick
    Ireland
  • Beckman Coulter Diagnostics
    Manager, Manufacturing Science
    Beckman Coulter Diagnostics Jan 2022 - Present
    County Clare, Ireland
  • Centre For Project Management - University Of Limerick
    Moderator For Project Management
    Centre For Project Management - University Of Limerick Sep 2021 - May 2023
    Limerick, County Limerick, Ireland
    Course work assessment and grading of assignments
  • Technopath Clinical Diagnostics
    R&D Manager
    Technopath Clinical Diagnostics Nov 2013 - Dec 2021
    County Tipperary, Ireland
    Management of the R&D function, assuming responsibility for resourcing and leading the R&D team to deliver new products on time and within budget in accordance with the company business plan.Product Development/Change/Improvement/Project Management, working directly with the Quality Organisation to ISO13485, 21 CFR 820 and ISO14971 standardsProject ManagerDesign Control and Change Management SpecialistRisk Management Specialist
  • Technopath
    R&D Quality Engineer
    Technopath May 2012 - Nov 2013
    Ballina, County Tipperary
    Representative for quality assurance in the design and development process, translating quality standards and risk management standards into processes and procedures, relevant to new product design and design change processes. Responsible for the product Risk Management Files and the Post Market Surveillance process. Development, organisation and implementation of the product real time stability programs in compliance with CLSI standards and regulatory requirements.
  • Beckman Coulter
    Risk Management Specialist
    Beckman Coulter Dec 2011 - May 2012
    Ireland
    Responsible for the Risk Management process according to ISO14971 (Clare and Galway sites) through the entire product lifecycle.Provide support and leadership to all departments in all aspects of Risk Management.FMEA (failure modes and effects) facilitator and design coach.Trainer in Risk Management process.Maintenance of risk management filesCo-ordination of Post Market Surveillance.Participation in Design and Development activities from the Risk Management perspective.
  • Beckman Coulter
    Technical Services Manager
    Beckman Coulter Aug 2009 - Dec 2011
    County Clare, Ireland
    Reporting to the Operations ManagerManagement, coaching, training and development of the Technical Services team. Product maintenance support to the Organisation through raw material evaluation, feasibility studies supporting R&D and technical investigations. Additionally responsible for the management of the Value Assignment Operation for calibrators and controls.
  • Olympus Diagnostica Gmbh
    Technical Services Manager
    Olympus Diagnostica Gmbh Nov 2003 - Jul 2009
    Lismeehan, O Callaghans’ Mills, County Clare
    Reporting to the Operations ManagerManagement, coaching, training and development of the Technical Services team. Product maintenance support to the Organisation through raw material evaluation, feasibility studies supporting R&D and technical investigations. (From 2005) Additionally responsible for the management of the Value Assignment Operation for calibrators and controls.
  • Olympus Diagnostica Gmbh
    Project Manager, Research & Development
    Olympus Diagnostica Gmbh Oct 2001 - Nov 2003
    County Clare, Ireland
    Design Validation program, integrating customer requirements and validation objectivesRisk Analysis/Management Clinical field trials for IVDs .Training, development and management of R&D Biochemists appointed to projects.
  • Olympus Diagnostica Gmbh
    Senior Biochemist Evaluations And Applications
    Olympus Diagnostica Gmbh Aug 1999 - Oct 2001
    County Clare, Rieland
    Evaluation and application studies of new Olympus reagents, externally manufactured reagents and competitors’ reagents, on Olympus clinical systems. Analysis of technical dataDetermination of the effects of haemoglobin based oxygen carriers on Olympus systems. Generation of Clinical Chemistry Production SOPs, specifications (product and quality control), with regard to new formulations or improvements to existing ones. Generation of technical reports for Olympus reagents relative to reagents from competitors. Technical Support for the Customer Support department at Olympus if necessary.
  • Olympus Diagnostica Gmbh
    Customer Support Specialist
    Olympus Diagnostica Gmbh Feb 1998 - Aug 1999
    County Clare, Ireland
    Customer Support Specialist for largest customer - Olympus America IncResponsible for the handling of customer complaints and enquiries involving technical investigations of a wide range of chemistry issues to identify root cause. Responsible for liasing with internal groups (Research & Development, Quality Assurance, Quality Control, Logistics, Packaging Development) and original external manufacturers (OEMs) to ensure resolution of confirmed complaints and other quality issues
  • Olympus Diagnostica Gmbh
    Formulation Biochemist
    Olympus Diagnostica Gmbh Apr 1997 - Feb 1998
    County Clare, Ireland
    Manufacture of clinical chemistry and immunology diagnostic reagents for in vitro diagnostic use. Preliminary/In-process quality control testing of manufactured reagents.
  • Flemming Diagnostics Gmbh
    Formulation Biochemist
    Flemming Diagnostics Gmbh Nov 1984 - Apr 1987
    County Clare, Ireland
    Manufacture of clinical chemistry and immunology diagnostic reagents for in vitro diagnostic use. Preliminary/In-process quality control testing of manufactured reagents

Helen Macmahon Skills

Design Control Quality Assurance Life Sciences Quality System Medical Devices Research And Development Failure Modes Analytic Problem Solving Commercial Assessment Stability Testing Technical Writing Biotechnology Fda Iso 13485 Product Development U.s. Food And Drug Administration Validation Standard Operating Procedure Gmp Capa Change Management Risk Management Continuous Improvement

Frequently Asked Questions about Helen Macmahon

What company does Helen Macmahon work for?

Helen Macmahon works for Centre For Project Management - University Of Limerick

What is Helen Macmahon's role at the current company?

Helen Macmahon's current role is Moderator for Project Management.

What is Helen Macmahon's email address?

Helen Macmahon's email address is hm****@****man.com

What skills is Helen Macmahon known for?

Helen Macmahon has skills like Design Control, Quality Assurance, Life Sciences, Quality System, Medical Devices, Research And Development, Failure Modes, Analytic Problem Solving, Commercial Assessment, Stability Testing, Technical Writing, Biotechnology.

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