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Curtis Egan is listed as Executive Quality Engineer at Certified Compliance Solutions at Certified Compliance Solutions, a with 8 employees, based in Sun City, California, United States. AeroLeads shows phone signal with area code 951, 707, 858 and a matched LinkedIn profile for Curtis Egan.
Curtis Egan previously worked as Principal Quality Engineer at Certified Compliance Solutions and Executive Quality Engineer at Certified Compliance Solutions. Curtis Egan holds Ba, Computer Video Imaging from Cogswell Polytechnical College.
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A proud employee of Certified Compliance Solutions, Curtis is an accomplished Medical Device Quality, Regulatory Compliance and Design expert with 16 years of experience in medical device validation and documentation, Supplier Quality, Quality, Quality Systems & Regulatory Compliance. Strategic, skilled and recognized as a “Gets it done” individual with strong interpersonal skills. Skilled in medical devices, safety risk management, validation/verification. Has a strong understanding how to integrate regulatory compliance and good business practices. Key areas of expertise include:• Lead Auditor in mock inspections for FDA readiness• Front and back room support in FDA investigations• 21CFR Part 820• 21CFR Part 11• ISO 13485• CAPA Management• Process Validations IQ / OQ / PQ / PPQ• Facilities Validation • Regulatory Compliance System Development• World Wide Complaint Management• Quality Control• Risk ManagementIndustry Experience• Class 1 2 and 3 Medical Device • Medical Device Quality and Regulatory Documentation• 510(k) documentation and submission• Quality Systems Audits• FDA Audits / Support• IEC 60601• IEC 62304• ISO 14644• ISO 9001 Internal Auditor• ISO 13485 Internal Auditor• Design Controls • Safety Risk Management • Software/Hardware Validation • 21 CFR Part 11• FDA Regulator Training (11, 211, 814, 820)• Gas Systems Validation• Clean Room ValidationExperience:• 16 years experience in medical device industry• 16 years experience in software validation• 9 years equipment validation• 6 years facility/utility/clean room validation• 16 years quality system experience• 10 years auditor experience As the lead in multiple validation projects, has been recognized for the ability to build a team environment and push through tight timelines to achieve a the goals in a manner that has proven defensible in audits.Supported multiple FDA Investigations in the US, Europe and Japan.
Listed skills include Validation, Fda, Capa, Quality System, and 29 others.
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Greater San Diego Area
Experience:• 17 years experience in medical device industry• 17 years experience in software validation• 12 years equipment validation• 8 years facility/utility/clean room validation• 17 years quality system experience• 12 years auditor experience
Manage Validation Master Plans (VMPs) andassociated reports related to new productdevelopment and existing production processes,systems, and controls.Perform validation assessment on ChangeManagement documentation including, but notlimited to document changes, system changes, andprocess changes.Track and report validation progress of corporatevalidation projects through departmental projecttracking tools.Represent Abbott Vascular during internal andexternal audits of validation projects anddocumentation.Write validation documentation against productionprocesses and systems in compliance to internaland external requirements.Manage the execution of validation protocols, asprotocol directors, in assurance of timely and costefficient completion through specialized experienceand training.Evaluate validation results of validation protocolexecutions employing specialized experience andtraining.Software ValidationEquipment ValidationGas Systems ValidationClean Room ValidationHVAC ValidationBMS/FMS ValidationArchitectural FinishesCAPA InvestigatorCAPA Initiator/EvaluatorCAPA Resolution Planner
Writing, editing, and approving the following:o SOPso Risk Analysiso Requirement Specificationso Traceability Matrixeso Software Test Procedureso Validation Reportso Validation Planso IQ, OQ, PQo 510(k) Submissionso Code Reviewso Design Descriptionso Design and Development Planso Change management DocumentationExecuting, modifying and defending the following:o Installation Qualificationso Operational Qualificationso Performance Qualificationso Process Qualificationso Software Test Protocolso System Test ProtocolsImplementing Quality SystemsConducting Audits of validations, processes andquality systemsConduct internal Quality Assurance AuditsProject and Personnel Management
Other employees you can reach at certifiedcompliance.com. View company contacts for 8 employees →
Peggy Olivier
Colleague at Certified Compliance SolutionsLancaster, California, United States
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Dan Olivier
Colleague at Certified Compliance SolutionsSan Diego, California, United States
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Larry Harvey
Colleague at Certified Compliance SolutionsEl Cajon, California, United States
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Robert Esquivel
Colleague at Certified Compliance SolutionsVista, California, United States
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Activities and Societies: Member of the ASB
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Curtis Egan works for Certified Compliance Solutions.
Curtis Egan is listed as Executive Quality Engineer at Certified Compliance Solutions at Certified Compliance Solutions.
AeroLeads has found 7 phone signal(s) with area code 951, 707, 858 for Curtis Egan at Certified Compliance Solutions.
Curtis Egan is based in Sun City, California, United States while working with Certified Compliance Solutions.
Curtis Egan has worked for Certified Compliance Solutions, Abbott Vascular Devices, Certified Software Solutions, Certified Software, and Imaginengine.
Curtis Egan's colleagues at Certified Compliance Solutions include Peggy Olivier, Dan Olivier, Larry Harvey, and Robert Esquivel.
You can use AeroLeads to view verified contact signals for Curtis Egan at Certified Compliance Solutions, including work email, phone, and LinkedIn data when available.
Curtis Egan holds Ba, Computer Video Imaging from Cogswell Polytechnical College.
Curtis Egan is listed with skills including Validation, Fda, Capa, Quality System, 21 Cfr Part 11, V&V, Iso 13485, and Design Control.
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