Lissy Hesser, CMQ/OE
Director, Quality Management Systems at physIQ- Claim this Profile
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Bio
Felix Martinson
I had the pleasure to work with Lissy for several years. Lissy was always helpful, knowledgeable and supportive. Her sharp intellect and positive attitude made a difference for me on multiple occasions. Lissy understands the regulatory expectations and practical applications thereof. I would be more than happy to have Lissy on my team!
Sherie White
I knew Lissy Heser as my supervisor while in the Document Control Group at KV Pharmaceutical. She is very detailed and conscientious; a professional who helped her team and maintained ethical perspective under great duress. She used her knowledge, skills and perseverance to move an archaic documentation process into the 21st century; which was not an easy task. If I had the opportunity, I would work with Lissy again.
Felix Martinson
I had the pleasure to work with Lissy for several years. Lissy was always helpful, knowledgeable and supportive. Her sharp intellect and positive attitude made a difference for me on multiple occasions. Lissy understands the regulatory expectations and practical applications thereof. I would be more than happy to have Lissy on my team!
Sherie White
I knew Lissy Heser as my supervisor while in the Document Control Group at KV Pharmaceutical. She is very detailed and conscientious; a professional who helped her team and maintained ethical perspective under great duress. She used her knowledge, skills and perseverance to move an archaic documentation process into the 21st century; which was not an easy task. If I had the opportunity, I would work with Lissy again.
Felix Martinson
I had the pleasure to work with Lissy for several years. Lissy was always helpful, knowledgeable and supportive. Her sharp intellect and positive attitude made a difference for me on multiple occasions. Lissy understands the regulatory expectations and practical applications thereof. I would be more than happy to have Lissy on my team!
Sherie White
I knew Lissy Heser as my supervisor while in the Document Control Group at KV Pharmaceutical. She is very detailed and conscientious; a professional who helped her team and maintained ethical perspective under great duress. She used her knowledge, skills and perseverance to move an archaic documentation process into the 21st century; which was not an easy task. If I had the opportunity, I would work with Lissy again.
Felix Martinson
I had the pleasure to work with Lissy for several years. Lissy was always helpful, knowledgeable and supportive. Her sharp intellect and positive attitude made a difference for me on multiple occasions. Lissy understands the regulatory expectations and practical applications thereof. I would be more than happy to have Lissy on my team!
Sherie White
I knew Lissy Heser as my supervisor while in the Document Control Group at KV Pharmaceutical. She is very detailed and conscientious; a professional who helped her team and maintained ethical perspective under great duress. She used her knowledge, skills and perseverance to move an archaic documentation process into the 21st century; which was not an easy task. If I had the opportunity, I would work with Lissy again.
Credentials
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ASQ Certified Manager of Quality/Organizational Excellence
ASQ - World HeadquartersSep, 2021- Nov, 2024 -
ISO 13485 Lead Auditor
BSI LearningDec, 2009- Nov, 2024
Experience
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physIQ
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United States
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Software Development
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1 - 100 Employee
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Director, Quality Management Systems
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Mar 2022 - Present
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Abbott
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United States
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Hospitals and Health Care
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700 & Above Employee
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May 2020 - Mar 2022
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May 2020 - Oct 2021
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Manager, Quality Management System
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Oct 2018 - Oct 2021
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Independent Contractor
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Jan 2016 - May 2020
Contract positions through Lexamed (Sr. Consultant), Automated Systems, Inc. (ASI), and others to provide quality consulting, technical writing, and remediation/improvement activities. Contract positions through Lexamed (Sr. Consultant), Automated Systems, Inc. (ASI), and others to provide quality consulting, technical writing, and remediation/improvement activities.
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ASO Worldwide
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Afghanistan
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Consumer Goods
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100 - 200 Employee
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Quality Assurance Manager
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Jan 2018 - Oct 2018
Management of multiple sites for operational quality and quality system. Developed and deployed strategies to achieve ISO 13485:2016 certification for multiple sites. Management of multiple sites for operational quality and quality system. Developed and deployed strategies to achieve ISO 13485:2016 certification for multiple sites.
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Medtronic
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Quality Assurance Manager
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Jul 2013 - Dec 2015
Developed and deployed medical device manufacturing (reprocessing) quality system for new business venture. Developed and deployed medical device manufacturing (reprocessing) quality system for new business venture.
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Covidien (Medtronic Minimally Invasive Therapies Group)
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Feb 2009 - Jul 2013
Site QA management for site that manufactures accessories for medical devices and performs factory service of finished devices. Responsible for management of quality assurance/quality management systems/quality control functions for the site, including all aspects of the quality system. Redesigned quality system and achieved site's initial ISO 13485 quality system certification.
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Oct 2008 - Feb 2010
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Mar 2008 - Oct 2008
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2003 - 2008
Developed and deployed change management system to ensure the evaluation, planning, implementation, and reporting of changes to products, processes, and systems were appropriately addressed.
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2003 - 2008
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KV Pharmaceutical
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Document Control Supervisor
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2003 - 2008
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Roche
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Switzerland
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Biotechnology Research
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700 & Above Employee
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Oct 2002 - Apr 2003
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2002 - 2003
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Document Coordinator
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1999 - 2002
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Document Coordinator
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1999 - 2002
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Document Coordinator
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1999 - 2002
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Education
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2012 - 2013
University of Phoenix
Associate of Arts (A.A.), Business Administration and Management, General -
Indiana University-Purdue University at Indianapolis
none, Business Administration and Management, General
Community
