Manager, Quality Systems and Regulatory Affairs

• Jun 2017 - Present

QA Engineer, V & V

• Aug 2016 - May 2017

Authored various protocols (IQ, OQ, PQ ,TIMV, VARS, VPP, SVR) and reports for Software and Process Validation for Philips Cleveland Parts Organization testing and repairing of service components. Participated in pFMEA documentation for the individual processes. Authored various protocols (IQ, OQ, PQ ,TIMV, VARS, VPP, SVR) and reports for Software and Process Validation for Philips Cleveland Parts Organization testing and repairing of service components. Participated in pFMEA documentation for the individual processes.

Sr. Quality Engineer

• Aug 2015 - May 2016

Senior Quality Engineer (Contract) Responsible for the generation of System Verification test cases, using ALM software, for the Veyron PET/CT Scanning System. Maintaining traceability of test cases to the System Requirements to ensure complete coverage of the requirements. Prepared the required documentation to formally release the generated test cases using Agile. Extensive interactions with Subject Matter Experts, manufacturing and design personal. Senior Quality Engineer (Contract) Responsible for the generation of System Verification test cases, using ALM software, for the Veyron PET/CT Scanning System. Maintaining traceability of test cases to the System Requirements to ensure complete coverage of the requirements. Prepared the required documentation to formally release the generated test cases using Agile. Extensive interactions with Subject Matter Experts, manufacturing and design personal.

Quality System Manager

• Sep 2013 - Jul 2015

Responsible for establishing an entire quality system that meets the requirements of FDA, ISO 13485 and MDD at a new medical device startup. Investigated and selected a notified body for the ISO and CE Mark certifications and obtained ISO 13485 certification for the facility. Searched and selected the software supplier for the generation of the eCRF documents and lead in the development of these documents. .Assisted in the planning and coordination for the Multi-Site Clinical Trial. Performing the Monitoring activities for the Multi-Site clinical trial. Leading the Supplier Qualification process including conducting supplier quality audits. Mentoring of the Engineering staff in the regulatory requirements for FDA, ISO and MDD. Reviewed and approved NCMRs for supplier correction activities. Show less

Director, Quality Systems

• Oct 2011 - Aug 2013

Responsible for directing the organizations Quality System (QA/QC) activities insuring that all products/services exceed the corporate and/or customer’s requirements in addition to the requirements of the regulating bodies (FDA, ISO, MDD). Manage both the HCA Process and Sourcing Validation Teams while generating the Validation documentation for HCM projects. Manages the Corrective Action/Preventative Action (CAPA) system for both internal and external requests. Manage the Non-Conforming Material Review (NCMR) system for both internal and external issues. Performs internal/external audits. Facilities weekly Quality meetings with our two major suppliers of OTC products and the HCM Quality Manager. Provides compliance support to NPD and Marketing teams on new and continuous improvement projects. Manage one direct report (CAPA/Complaint Manager) and 3 ½ indirect reports (QA Inspectors). Show less

Quality Systems Manager

• May 2005 - Sep 2011

Serve as only Quality Systems Manager of Center supporting rehabilitation research by adapting cross-cutting foundational technical platforms to meet specific needs for advanced prosthetic systems, sensory aids, and other clinical applications. In charge of establishing a Quality System meeting the requirements of the FDA at a research/academic organization. Prepare numerous Standard Operating Procedures (SOPs), a Quality Plan and other Quality procedures. Conduct training on SOPs. Prepare, review and submit IDE submissions and IDE addendums. Create NCMRs for all received materials and then recommend the resulting actions. Prepare and submit Annual Reports and Current Investigator’s listing for approved IDEs. Prepare, review and submit IRB protocols and informed consent forms. Prepare Design Control documents as templates for principal investigators and other engineering staff. Make presentations to various levels of the organization on Quality System requirements and Quality System documentation. Establish a Supplier Quality program to include SOPs, forms and a supplier survey to determine the need for audits. Conduct annual supplier audits on the 3 major suppliers and qualify 5 others through the survey analysis. Serve as point man for the external sterilization of all the devices used by our clinical investigators, provide the same service to Cleveland FES Center investigators and an external startup company licensing our technology. Work with the sterilizer to obtain a validated sterilization cycle. Represented the Center at local and national conferences. Mentor new and junior staff. Show less

Senior Manufacturing Engineer/Quality Control

• Feb 2004 - May 2005

Serve as only Quality Systems Manager of Center supporting rehabilitation research by adapting cross-cutting foundational technical platforms to meet specific needs for advanced prosthetic systems, sensory aids, and other clinical applications. In charge of establishing a Quality System meeting the requirements of the FDA at a research/academic organization. Prepare numerous Standard Operating Procedures (SOPs), a Quality Plan and other Quality procedures. Conduct training on SOPs. Prepare, review and submit IDE submissions and IDE addendums. Create NCMRs for all received materials and then recommend the resulting actions. Prepare and submit Annual Reports and Current Investigator’s listing for approved IDEs. Prepare, review and submit IRB protocols and informed consent forms. Prepare Design Control documents as templates for principal investigators and other engineering staff. Make presentations to various levels of the organization on Quality System requirements and Quality System documentation. Establish a Supplier Quality program to include SOPs, forms and a supplier survey to determine the need for audits. Conduct annual supplier audits on the 3 major suppliers and qualify 5 others through the survey analysis. Serve as point man for the external sterilization of all the devices used by our clinical investigators, provide the same service to Cleveland FES Center investigators and an external startup company licensing our technology. Work with the sterilizer to obtain a validated sterilization cycle. Represented the Center at local and national conferences. Mentor new and junior staff. Show less

Validation Engineer

• Jul 2003 - Dec 2003

Prepared validation protocols for a small parential pharmaceutical manufacturing company. Assisted facility engineer in the installation of new equipment and the construction of the facility. Assisted in the resolution of the non-conformances discovered during the installation and qualifications of the manufacturing equipment. Prepared validation protocols for a small parential pharmaceutical manufacturing company. Assisted facility engineer in the installation of new equipment and the construction of the facility. Assisted in the resolution of the non-conformances discovered during the installation and qualifications of the manufacturing equipment.

Senior Validation Engineer/ Facilities Manager

• Mar 2001 - Mar 2003

Managed a staff of seven engineers covering the manufacture of STERIS SYSTEM 1, the chemical packaging of STERIS 20 (the sterilant utilized in the SYSTEM 1), and new product process development. • Authored, approved and executed validation protocols for the equipment utilized throughout the facility. • Managed facility issues including control of the HVAC system, hazardous waste collection and disposal, EPA monitoring and reporting activities, and OSHA activities. • Managed the resolution of all non-conformances observed during incoming inspection and production. • DOT certified for Hazardous Waste management. • Certified Internal Auditor for ISO. • Expert in 21 CFR 820 (QSR) 21 CFR Part 11, 21 CFR 210-211 (cGMP), ISO 9000, and ISO 13485. Process Validation Engineer, 03/01 – 01/02 • Authored, approved and executed validation protocols for over 40 pieces of equipment, packaging lines and test equipment utilized throughout the facility. • Revised existing procedures to fall within guidelines of the GHTF Guidance document for process validation from the FDA. • Trained various personnel throughout the facility on validation requirements, methods and procedures Show less