Oversaw and managed QC process to ensure compliance with all standards and regulations. Led 15-25 direct and indirect reports, guided engineers to incorporate Hazardous Substance and Human Factors as required by laws and internal specifications and provided support to cross-functional teams with responses to Regulatory and Notified Body questions. Followed PMO schedule to ensure legacy design history files are modified to design control specifications for medical device instruments and implants. Conducted audits and inspections to identify and drive improvements, and supported Notified Body technical file reviews, question responses, and virtual and onsite reviews. • Led remediation of 13K+ SKUs and managed quality of 60 technical files and 57 projects.• Realigned focus for failing team by clarifying objectives, eliminating non-critical tasks, creating accountability for team members, and aligning individual and team goals, resulting in on-time delivery within six months.• Spearheaded cross-functional hiring and training initiative to resolve critical resource constraints and bring project delivery in alignment with internal goals.

Managed 6 direct and indirect reports, maintained quality system in functional areas of custom, patient specific and stocked products, and ensured compliance and release of product according to specifications. Performed gap assessment and QMS updates for MDSAP compliance, and supported revision of quality system to encompass utilization, qualification and validation of innovative technologies including MRI, X-Ray, and product software in product realization process. • Oversaw quality function associated with servicing and repairing orthopaedic instruments, led team to transfer endoscopy product into orthopaedic division, and supervised design control function including FMEA and PFMEA for Class I and II medical devices along with custom product control.• Led cross-functional team to create and implement software medical device quality system and identify root causes in response to CAPA activities.• Performed management review, supported 510K activities, provided employee development and mentoring, and acted as UDI implementation team member.