Maria Blake Email & Phone Number

With over 20 years of experience in quality assurance and regulatory compliance within the medical device manufacturing industry, I am a dedicated and accomplished leader specializing in laser systems and medical devices. My expertise spans across GMP, ISO, OSHA, and FDA regulations, ensuring that all products and processes adhere to the highest standards of quality and safety.At Biolase Technologies, I serve as the Sr. Quality Assurance Manager, Deputy Management Representative, Internal Lead Auditor, and QA Supervisor. In this role, I have successfully prepared the company for annual MDCERT audits, addressed non conformances, and conducted comprehensive Management Reviews, Internal Audits, and Monthly Failures Reports. I have a proven track record of fostering quality improvement through strategic planning and implementation, maintaining close communication with internal and external stakeholders to resolve product failures efficiently.My management capabilities extend to overseeing internal operations, including developing audit schedules, managing document control and calibration processes, and handling daily case reviews. As a QC Supervisor, I have led the quality and regulatory compliance efforts, standardized GMP programs, and implemented electronic document management systems to enhance overall production efficiency.Prior to my current role, I was a Production Supervisor at Applied Medical Resources, where I managed SPC, Injection Molding, Insert Molding, and Extrusion areas. I effectively supervised a team of 40 members, facilitated shift-change meetings, and maintained accurate Bill of Materials.My career began at Abbot Laboratories as a QC Lead and R&D Technician, where I led a team of Quality Inspectors, conducted final catheter inspections, and collaborated with Engineering on new product development.I am proficient in various quality systems and tools, including GP, Arena, Sales Force, QCBD, CRM, SAP, and SharePoint. My technical expertise encompasses laser manufacturing, injection molding, and catheter balloon production. Fluent in both English and Spanish, I possess strong problem-solving capabilities, ensuring efficient issue resolution and continuous improvement.I am passionate about leveraging my extensive experience and skills to drive excellence in quality assurance and regulatory compliance, contributing to the success and innovation of forward-thinking organizations in the medical device industry.