- Established a global Case for Quality program across six sites to identify and implement quality-focused continuous improvement initiatives- Manage team of six engineers and analysts in the Quality Compliance, including Post-Market Surveillance, Corrective and Preventive Actions, Health Hazard Evaluations, and Field Actions- Implemented a harmonized Quality Planning process across the business- Designed and instituted a project management process utilizing Smartsheet- Serve as a leader of the CAPA Review Board and HHE/Field Action Committee- Led computer system validation of an Enterprise Resource Planning system across multiple sites- Represent Quality Compliance and continuous improvement during internal and external audits and inspections

- Managed team of 10 engineers and developers in the areas of Design Control, Risk Management, Engineering Systems, and Post-Market Surveillance Investigations- Represented Design Control and Risk Management during internal and external audits and inspections- Provided compliance, engineering, and risk management expertise for regulatory submissions and inquiries- Served as a member of the CAPA Review Board and Corrections and Removals Committee- Design Control and Risk Management SME for EU MDR transition and submissions- Team leadership for EU MDR transition planning and execution- Created Risk Assessment tool using Microsoft Excel and VBA

- Managed team with ownership of Design Control, Risk Management, Engineering Systems, and Post-Market Surveillance Investigations- Developed and maintained procedures and templates for design control, risk management, and Post-Market Surveillance- Handled Design Control and Risk Management due diligence relating to acquisitions - Participated in back room and front room of internal and external audits and inspections- Led cross-functional teams through remediation of all Design History Files- CAPA owner for systemic Design Control and Risk Management non-conformances and improvements- Engineering representative on CAPA Review Board

- Managed team in identifying areas of opportunity throughout company processes and implementing improvements- Led cross-functional team to update and improve Design History Files for all products- Developed and revised procedures for design control, risk management, and biological safety evaluation- Provided engineering support for regulatory submissions- Created forecast and purchasing model utilizing Microsoft Excel and VBA as an operations process improvement

- Supported regulatory submissions for multiple products- Kept technical specifications up to date, including gap analysis and testing- Achieved cross-functional consensus on risk management process and documentation- Led the completion and closure of numerous Corrective and Preventative Actions

- Designed, manufactured, and tested prototypes of endoscopic devices - Organized pre-clinical animal/cadaver studies- Process development including polymer extrusion, metal braiding, and laser welding

Designed, prototyped, and tested endoscopic closure device, microfluidic platform for impedance analysis of a cell monolayer, and minimally invasive proximal femoral fracture fixation device

Designed, prototyped, and tested orthopedic implants and instrumentationComplaint Analysis