Niamh Nolan

Lecturer in Quality @Atlantic Technological University

Galway, IE
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2024 — Present

Lecturer in Quality @Atlantic Technological University

Lecturer in QualityPart-Time Specified Purpose ContractSchool of Science and ComputingResponsible for actively contributing to the academic direction of courses through teaching, research, assessment, and administration.Level 8 (Degree) and 9 (Master’s Degree) Programmes.Current Teaching Modules include:Global Regulatory Strategies for Medical Technologies (5813)Design Quality Assurance (4018)Regulatory Affairs and Compliance Auditing (1617)

EDUCATION

1990 — 1992

Regional Technical College Galway (RTC)

National Certification in Science (Applied Chemistry)

1993 — 1994

University of Wolverhampton

BSc (Hons) in Applied Sciences, ‘Chemistry’

N/A

Regional Technical College, Cork

Certificate in Quality Assurance

2022

University of Galway

Masters in Medical Technology Regulatory Affairs

1992 — 1993

Regional Technical College Galway (RTC)

Diploma in Fine Chemicals Pharmaceuticals

SKILLS

UsabilityMinitabFda GmpSix SigmaQuality AuditingPost Market SurveillanceDesign of ExperimentsCathetersChange ManagementSupplier QualityIso 14971CqeDesign for Six SigmaQuality ControlGmpCertified Lead AuditorV&VVerification and Validation (V&V)21 Cfr Part 11FmeaIso 13485U.s. Title 21 Cfr Part 11 RegulationU.s. Food and Drug Administration (Fda)Gage R&RCe MarkingDmaicDesign ControlMedical DevicesCapaProduct DevelopmentRoot Cause AnalysisCorrective and Preventive Action (Capa)Project ManagementFdaSpcProblem SolvingBiomedical EngineeringTechnical WritingValidationContinuous Improvement

ABOUT NIAMH NOLAN

With over 28 years of experience in regulatory compliance and quality systems, I bring a deep understanding of medical technologies to my dual roles as Lecturer in Regulatory Compliance at the University of Galway and Lecturer in Quality at Atlantic Technological University. My teaching spans Level 8 and 9 programs, covering modules like risk management, regulatory compliance, and quality systems, where I aim to bridge academic theory with real-world applications to prepare students for the evolving healthcare landscape. Alongside my academic contributions, I serve as a Quality Assurance & Regulatory Affairs Consultant, assisting healthcare manufacturers in optimizing quality management systems and ensuring compliance with global regulatory standards. My expertise in design assurance, auditing, and risk management supports organizations in achieving operational excellence, fostering innovation, and maintaining the highest standards in medical technology.

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Niamh Nolan — Lecturer in Quality at Atlantic Technological University in Galway, IE | Unifers