Sheryl Wolff

Background

About Sheryl Wolff

I have over 25 years experience in Quality Assurance. My goal as a Quality Assurance Consultant is to work collaboratively and cross-functionally for clients. I work to build and/or support strong Quality Systems that are compliant and sustainable, that allow my clients to meet and exceed regulatory standards. I started my career as a Medical Technologist. I transferred those skills to Medical Diagnostics at a Fortune 500 Medical Diagnostics company, where I went on to a successful career in their organization and leadership team. After relocating to Colorado, I consulted in the Medical Device industry establishing ISO 13485 regulatory compliant quality systems for domestic and international clients. I returned to the clinical laboratory in management to combine my technical and QA background to enhance the laboratory environment. I returned to a more true QA role and world in the tissue banking and medical device industries. All of the roles in my career have these skills in common: leadership, compliance, process improvement, cost and efficiency savings and helping the customer and/or client. My QA experience includes product, site, and management level quality positions where I worked collaboratively to achieve goals across departments at all levels. I've also worked at small companies where everyone is on the team. My strengths include process improvement with the goal of efficiencies and cost savings, strategic planning, quality management systems, resource management, CAPA, NCRs, risk management, auditing, training, and complaint investigations and handling. In addition, I have implemented an eQMS system, designed and enhanced the processes for organizational procedures, provided technical documentation and facilitated training to successfully meet customer requirements.