Spearheaded completion of investigation summaries, root cause analysis, corrective action and MDR submissions as part of multi-tiered remediation project.- Served as an information resource and technical “go to” for QA initiatives, successfully contributing to new SOPs to handle a 400% increase in complaint volume. - Mitigated risk exposure as a cross functional team member deploying investigational techniques to satisfy regulatory requirements and deliver accuracy in written customer and FDA responses. Show less

Drove business unit KPI for complaints over 90 days to imaging systems target of less than 10% and achieved Best in Class for all of Imaging Systems.- Reengineered the business unit to ensure compliance for open complaints by developing integration strategies, checking results bi-weekly meetings and distributing data for improved clarity amongst team members. - Achieved QA in handling complaints by managing the trend analysis for all stages of the program to align results within controlled metrics for engineering, operations, customer support, sales and marketing activities.- Delivered transparency as a key contributor to all internal and external audits (FDA) for the business unit and reported analysis for quarterly business and management reviews.- Boosted efficiency by developing a complaint ISO 13485, FDA 21 CFR 820 process and procedure.- Advanced corrective and preventive actions (CAPA) required for the complaint handling process and procedure. Show less

* KERECIS is an Acellular Fish Skin Rich in Omega3 Fatty Acids. * ARTELON is synthetic provisional matrix. * BioMonde- Larval therapy

Increase accuracy in achieving goals by developing, establishing, integrating and improving all work instructions and process maps to align with ISO 9001:2008 standards.- Improve results by investigating root cause analysis and proactively creating corrective action plans for all quality observations and customer complaints.- Advance QA by encouraging cross-functional teams to increase transparency and communication while supporting efficient implementation of the Quality Management System. - Safeguard the organization by conducting Internal and External Quality Systems Audits for CAPA integration. - Leverage an expertise in Six Sigma methodologies to monitor and measure trends, resulting in an improved customer experience, optimized operational efficiency and lowered cost. - Enhance employee integration by training and mentoring direct reports to develop the necessary success skills to achieve initiatives. Show less