Single Source is a medical device contract manufacturer located in North Liberty and Merriam, Indiana. We specialize in precision manufacturing for surgical instruments and implants in all segments of the orthopedic industry. Our goal is to create long-term relationships by providing quality products, on time at a competitive price.

Business services firm offering Accounting, financial reporting, financial analysis, leadership and business consulting

Upon completion of the acquisition of Nextremity Solutions, I maintained all prior leadership responsibilities, with the addition of sales distribution, field logistics, and customer service.

Nextremity Solutions is a strategic commercialization company that is focused on bringing innovative medical devices to the market. We partner with strategic clients to create distribution partnerships with products that are innovative and market ready. My responsibilities cover operations, supply chain management, quality systems, and regulatory affairs. We have a fantastic team of dedicated and innovative problem solvers, of which I am lucky to be a part.

Responsible for hiring and leading a team of Quality Engineers focused on new product development. The initial focus of the role was geared towards the design transfer phase, specifically the External Manufacturing and the process qualification activities. Increasing responsibilities now include Quality Systems and procedures for the NPD process and additional leadership opportunities. This role gives me the opportunity to think strategically about the business as well as mentor and coach our engineering team members into a strong well performing function. We Interface directly with our design teams to ensure the design intent is met through the verification and validation activities, as well as being controlled though process monitoring during the manufacturing process. We Assist suppliers with manufacturing process troubleshooting, inspection technique development, process validation, and all process qualification documentation.

Project Manager for a global supplier validation remediation team with 5 direct reports · Set up project structure and helped set milestones for team · Progress reporting and accountability with team · Reporting to senior leadership on progress and resource management · Oversee supplier process validation efforts (IQ, OQ, & PQ)MedAccred representative for DePuy Synthes · Representation of Heat Treat task group, Process Validation sub team, and Quality Management sub group. · Member of the MedAccred Management CouncilLeader of an FDA warning letter remediation project at a critical business supplier · Focused on Process Validation and Test Method Validation · Assisted in the successful development of the Test Method and Process Validation SOP's · Coached supplier through the test method and process validations (IQ, OQ, & PQ)Partner with suppliers to perform root cause analysis and drive corrective actionsUse risk based methods for control of suppliers of outsourced products and processesDevelopment of supplier first article inspection requirementsLead process FMEA, risk mitigation and control activities

Assist with implementation of Lean Manufacturing Principles