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Helen Cusack Location
Ireland
Helen Cusack Work
Director of Quality @ (February 2024 - Present)
Quality Manager @ (November 2014 - Present)
Senior Quality and Regulatory Engineer @ (August 2012 - November 2014)
Design Assurance Engineer @ Boston Scientific Ballybrit Galway (November 2008 - August 2012)
Quality Operations Engineer @ (April 2007 - November 2008)
Laboratory Manager and Plant Microbiologist @ Abbott Ireland Cootehill Cavan (April 2005 - April 2007)
Capa and Complaints Co-Ordinator @ (June 2004 - September 2005)
Quality Assurance Officer @ (June 2003 - June 2004)
Microbiological Laboratory Technician @ (June 2002 - September 2002)
Analytical and Micro Laboratory Technician @ Bailie Foods (May 1999 - June 2002)
Helen Cusack Education
National University of Ireland, Galway 2010-2011
National University of Ireland, Galway
Bachelor Of Science (Microbiology)
1998-2003
Loreto College 1993-1998
Helen Cusack Skills
GMP
CAPA
Quality Auditing
Quality Assurance
FDA
Microbiology
ISO 13485
Medical Devices
Quality System
Design Control
5S
Lean Manufacturing Experienced (OEE / BE) - Green Belt Certified 2008
Iso 9000
Validation
ISO 14971
V&V
Certified Internal QMS Auditor - IQC trained
Competent facilitator of Kaizen and Pathwise events to establish root cause
People management; 7 years supervisory experience
Trained interviewer; competency based interviewing (2010)
Confident trainer and experienced meeting chair
Certified ISO 13485:2012 Lead Auditor - IQC trained 2014
Experienced in EtO Ster. Validation & Routine Control (ISO 11135 & 11737)
Experienced in medical device biological evaluations (ISO 10993)
Experienced in Medical Device Biological Evaluations Iso 10993
Iqc Trained 2014
2012 Lead Auditor
7 Years Supervisory Experience
Competency Based Interviewing 2010
Certified Internal Qms Auditor
Certified Iso 13485
Trained Interviewer
Lean Manufacturing Experienced Oee
Green Belt Certified 2008
People Management
Iqc Trained
Experienced in Eto Ster. Validation and Routine Control
Experienced in Medical Device Biological Evaluations
Helen Cusack Summary
Helen Cusack, based in Ireland, is currently a Director of Quality at Freudenberg Medical. Helen Cusack brings experience from previous roles at Neuravi, Boston Scientific Ballybrit Galway and Merit Medical Systems, Inc.. Helen Cusack holds a 2010 - 2011 National University of Ireland, Galway. With a robust skill set that includes GMP, CAPA, Quality Auditing, Quality Assurance, FDA and more. Helen Cusack has 1 emails on RocketReach.
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