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David Leighty is listed as Validation Engineer at CONMED Corporation, based in Greensburg, Pennsylvania, United States. AeroLeads shows a work email signal at att.net, phone signal with area code 724, 423, and a matched LinkedIn profile for David Leighty.
David Leighty previously worked as Quality Engineer at Teleflex Incorporated and Validation Engineer at Terumo Cardiovascular Systems. David Leighty holds Business from Chaminade University Of Honolulu.
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AeroLeads found 1 current-domain work email signal for David Leighty. Compare company email patterns before reaching out.
An independent contractor, with 12 years of experience in the pharmaceutical and medical device industry and 10 more in pulp, paper, and petrochemical industry.An expert interpreting FDA pharmaceutical CFR Part 210, 211, medical devices Part 820, electronic records and signature Part 11, ISO 13485 and IEC 60601-1: 3nd ED compliance and technical writing. Provides software quality assurance for product development and authors standard operating procedures and training manuals. Effectively executes, and audits validation protocols for installation, operational, and performance qualification. For medical devices, provides similar activities to ensure compliance with required design verification and validation regulations, including labeling requirements.Verification & Validation Areas:Process, Utility, Thermal, Computer system, Control systems, Auditing, New product development, Test method validation, Project management.Specialties: Learns and adheres to company policies, applies FDA, ISO, and international regulations effectively. Writes clearly and concisely, validation documentation, work instructions, and final reports Transfers experience from 12 years of contracting experience from top-ranked companiesPlans and implements actions required for new product development and remediation efforts. Performs tasks with no direct supervision and within project teams.
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A career timeline built from the work history available for this profile.
Largo (Tampa Bay), FL, US
Team member on a validation team tasked with remediation and completion of the design history file for an AirSeal system by SurgiQuest. In addition, CAPA closures regarding service calls, software updates, validation master plans, and device history records are being performed. Risk management, supplier quality assurance, and lack of adequate testing are.
Wayne, PA, US
Team member on a validation team tasked with preparing and executing qualification activities related to moving several manufacturing activities to a new location. This includes the creation of new installation qualification packages, including test method validations for new and in-service applications.
Ann Arbor, Michigan, US
Team member on a validation team tasked with remedial and complete validation of a blood monitoring device. The specific tasks included writing, creating test parts, and administering test method validations for in-process testing and incoming quality inspections of vendor supplied components. Collaborated with the statistical department by conducting.
Gothenburg, SE
Team lead on a validation team tasked with remedial and complete validation of initially four product lines. Tasked with writing and executing OQ, PQ, TMV, Design Validation, and PPQ. Performed Gap Analysis of DHF for multiple medical devices/products. Remediated DHF by updating or generating missing documentation, and updating DHF Index to reflect most.
Leverkusen, North Rhine-Westphalia, DE
As part of the Design Assurance, Verification and Validation department, I wrote, reviewed, and executed protocols to support new product development for contrast injection systems used for CT and MRI procedures.This included labeling conforming to: BS EN 60601-1:2006, CAN/CSA C22.2 NO. 60601-1-08, ANSI/AAMI ES60601-1, 93/42/EEC, IEC TR 60878, 21 CFR 801.
Pennsauken, New Jersey, US
Team member on a validation team tasked with remediation and completion of the design history file for an AirSeal system by SurgiQuest. In addition, CAPA closures regarding service calls, software updates, validation master plans, and device history records are being performed. Risk management, supplier quality assurance, and lack of adequate testing are.
Somerset, New Jersey, US
Preparing and executing design verification and validation protocols for the CDI 500 Blood Monitoring System.
Freeport, Pennsylvania, US
Wrote and executed installation and operational qualifications for automated equipment used to machine stainless steel parts used in a variety of medical devices. Conducted ISO 13485 related audits and ensured compliancy for the Medical division of Oberg. Perform process validation to remediate the quality system regarding special treatments required to be.
St. Paul, Minnesota, US
Wrote and executed installation and operational qualifications for equipment used to manufacture ablation catheter assemblies. Wrote validation summary reports.
Validation Engineer, Boston Scientific, (01/09 – 05/08/09)Wrote changes to work instructions, flowcharts, and wrote equivalency reports supporting the launch of three new ablation products. Validation Engineer, Teleflex Medical, (06/08 – 12/08)Wrote process flow diagrams, qualification protocols, traceability matrices, and equipment requirement.
Assisted the new product development department in constructing traceability of tests to design requirement specifications. Approved verification testing and developed validation testing methods as required. Approved test methods assuring acceptance criteria compliance. Aided in transfer of process validation to the China facility.
Goose Creek, South Carolina, US
GE Healthcare, Wrote system verification and validation protocols. Assure traceability to system design requirements. Improve verification and validation methods.
US
Boston Scientific, Wrote the quality of verification and validation testing to ensure compliance for a new cardiac device. Wrote process risk assessment through PFMEA. Wrote design and process validation tracing to Software Design Specifications, User Requirement Specifications, and Functional Specifications. Approved design, installation, and operational.
Canonsburg, Pennsylvania, US
SAP implementation validation compliance and risk assessment. Managed change control system. Helped SAP contractors write design validation protocols in Mercury TestDirector. Qualified Mercury TestDirector
Hanover, Maryland, US
Banner PharmacapsValidation of new clinical trial drug production and packaging operation including facility and utility validation.
Validation of new clinical trail production facility.
Durham, North Carolina, US
Remediation of entire stent production operation.
London, United Kingdom, GB
Wyeth, SmithKline, Schering-Plough, Aventis Behring Wrote SOPs for validation library operations, disaster recovery, equipment operation, laboratory operation, electronic record retention, change control program, and factory acceptance. Perform gap analysis assessments for a pharmaceutical and medical device compliance, computer system validation for a.
Crystal River, FL, US
Modified computerized maintenance management applications for Georgia-Pacific, Oxydental Petroleum, City of Los Angeles, and TRW. Trained personnel and installed application at aforementioned company sites.
Washington, DC, US
Submarine nuclear propulsion plant operator, HVAC, diesel engine repair, Oxy-acetelene brazing, asbestos safety, repair parts inventory, and SubSafe compliance officer.
Quick answers generated from the profile data available on this page.
David Leighty works for CONMED Corporation.
David Leighty is listed as Validation Engineer at CONMED Corporation.
AeroLeads has found 1 work email signal at @att.net for David Leighty at CONMED Corporation.
AeroLeads has found 4 phone signal(s) with area code 724, 423 for David Leighty at CONMED Corporation.
David Leighty is based in Greensburg, Pennsylvania, United States while working with CONMED Corporation.
David Leighty has worked for Conmed Corporation, Teleflex Incorporated, Terumo Cardiovascular Systems, Maquet Getinge Group, and Bayer Healthcare.
You can use AeroLeads to view verified contact signals for David Leighty at CONMED Corporation, including work email, phone, and LinkedIn data when available.
David Leighty holds Business from Chaminade University Of Honolulu.
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