Head of US Quality, built a AS9100 QMS System from scratch to BSI Certification in 9 months.

Oxford Performance Materials, Inc. is a materials technology company, specializing in the manufacturing of PEKK high performance polymer and 3D printing of medical devices. Managing over one-third of company’ staff. Responsible for materials production, 3D printing manufacturing, inspection, quality control, logistics and supply chain management. Built a custom implant design department for the company’s craniomaxillofacial division, including hiring of the design engineering team, creation of SOPs, and validation of software and design process.Negotiated contracts to expand business in the materials and 3D printing market segments. Developed a robust supply chain for pellet and stock shape extrusion, using domestic outsourcing to reduce production lead-time and improve overall economics. Lead the expansion into private label production of finished millable blanks for dental CAD-CAM applications.Reduced overhead and increased margin for existing product lines through strategic partnerships. Supported compliance through active participation in FDA inspections, ISO and internal audits, and creation of supply agreements to ensure continued product quality and compliance. Member of the executive team, focusing on implementing business goals and company vision on an operational level.

Kelyniam Global Inc. is a medical device manufacturer, specializing in customized PEEK cranial/craniofacial implants.Developed a design/manufacture process that expedites delivery of a custom implant to the customer in 24 hours or lessCo-Authored a BSI Certified ISO 13485:2003 quality management system Author and creator of a successful 510K submission and approvalExperienced in ISO 9001, FDA 21 CFR Part 820, and ISO13485:2016Intellectual Property Work: Fixation Article for an Implant (US 20150173815 A1), Mounting Tab For a Cranial Implant (US D765843 S1), Cranial Implant Having an Anchor Channel (62/419,677), Flexible Spine Plate (62/725,212) Project work included; Cranial Implant Molding System, Craniofacial Plating Screw Development, Integrated Suturing System, Design and Patenting of Spine PlateApply Six Sigma and Lean Manufacturing principles to risk management and process planningPerform internal audits, lead inspection audit by the FDA, and certification audits by BSIAbove average oral and written communication skills with customers as well as team members Former Member of Board of Directors and TreasurerExperienced in company mergers & acquisitions, medical device startups, extensive rapid prototyping/3D printing, developing and mentoring engineering staff, financial statement preparation/reporting and coordination of internal audits

Cranston Holdings LLC was a rapid prototyping service bureau, utilizing an online quoting engine “Stereolithography.com” to sell prototypes worldwide.Strategically managed client base maximizing sales revenue and company growth an online instant quoting engine “Stereolithography.com”.Advanced company goals executing sophisticated vendor management for large outsourced prototyping projects.Comprehensively ensured effective maintenance & repair of 8 – Stereolithography - 3D Printing machines. Highlights:Championed client satisfaction manufacturing custom prototype parts for a wide customer base. Delivered high quality medical modeling for surgical planning, dental industry, and prosthetics (created models for models for trade shows, scale modeling, and finished consumer goods).Achieved long term project success for aerospace/defense customers Pratt & Whitney, Kaman Corporation, and SAIC.Delivered precision financial management executing all company accounting/bookkeeping for Business, and contract negotiations, securing loans and financing for business growth.Technologies: Stereolithography, 3D Printing, Laser Sintering, Metal Prototyping, Metal Plating, Rapid Tool Makers ((RTM), EnvisionTec, Revo Milling System and CNC Machinery.