David Leighty
About David Leighty
David Leighty is a Quality Engineer currently working at both CONMED Corporation and Teleflex Incorporated, with extensive experience in validation engineering and compliance in the pharmaceutical and medical device industries.
Company
David Leighty is currently employed at two companies: CONMED Corporation as a Validation Engineer in Milford, CT, and Teleflex Incorporated as a Quality Engineer in Chelmsford, MA. He has a long career history that includes roles at Terumo Cardiovascular Systems, Maquet Getinge Group, Bayer HealthCare, St. Jude Medical, and several other organizations.
Title
David Leighty holds the title of Quality Engineer. He has also served in various capacities including Validation Engineer and Software Quality Engineer across multiple industries, primarily focusing on the pharmaceutical and medical device sectors.
Education and Expertise
David Leighty studied at Chaminade University of Honolulu, achieving a degree in Business. He also studied Nuclear Physics at the Naval Postgraduate School, earning a certification as a Power Plant Operator, and studied Chemistry at Penn State. His expertise includes FDA pharmaceutical CFR Part 210 and 211, medical devices Part 820, electronic records and signatures Part 11 compliance, ISO 13485, and IEC 60601-1: 3rd ED compliance.
Experience in Validation and Quality Engineering
David Leighty has extensive experience in executing and auditing validation protocols for installation, operational, and performance qualification. His roles have required ensuring compliance with design verification and validation regulations, including labeling requirements for medical devices. He has worked on process, utility, thermal, computer systems, control systems, auditing, new product development, test method validation, and project management.
Independent Contracting Services
David Leighty has provided independent contracting services for the pharmaceutical and medical device industry for 12 years. His work includes interpreting and applying various regulations, providing software quality assurance for product development, authoring standard operating procedures, and training manuals. He plans and implements actions required for new product development and remediation efforts, performs tasks with minimal supervision, and is knowledgeable in risk management and supplier quality assurance.