Maria Blake Email & Phone Number

Corona, California, United States

In my role at Biolase Technologies, I lead quality assurance and regulatory compliance efforts within the medical device manufacturing sector. Key responsibilities and accomplishments include: Audit and Compliance Management: Prepared the company for annual MDCERT audits, addressing non conformances as Deputy Management Representative. Conducted Management Reviews, Internal Audits, and Monthly Failures Reports, enhancing quality monitoring. Internal Operations Oversight: Streamlined internal audits, managed document control and calibration processes, and ensured compliance through accurate document management. Reviewed and approved Engineering Change Orders (ECOs) and maintained archival processes. Quality Control Supervision: Oversaw regulatory compliance, standardized GMP programs, and implemented electronic document management systems. Developed test tools to ensure adherence to quality standards. Complaint Management: Managed complaints efficiently by reviewing files, conducting root-cause analysis, and generating trend reports. Coordinated with cross-functional teams for comprehensive complaint data and timely resolution. RMA/RO and NCMR Management: Improved RMA processing and managed inventory accuracy. Issued NCMRs, handled transactions, and collaborated with suppliers for evaluation and root-cause analysis. Training and Inspection: Verified training compliance, conducted tests for laser systems, and supported quality needs through final reviews of Device History Records (DHRs). Ensured meticulous inspection processes for incoming raw material, in-process, and final inspections.My role at Biolase Technologies has allowed me to leverage my extensive experience in quality assurance and regulatory compliance, driving continuous improvement and operational excellence to ensure the highest standards of product quality and efficiency.

Rancho Santa Margarita, California, United States

As a Production Supervisor at Applied Medical Resources, I managed day-to-day operations in a fast-paced manufacturing environment, focusing on SPC, Injection Molding, Insert Molding, and Extrusion areas. Key responsibilities and accomplishments include: Team Management: Supervised a dynamic team of 40 members, conducted performance evaluations, and addressed personnel issues, ensuring a productive work environment. Operational Efficiency: Facilitated shift-change meetings, communicated with Engineering to resolve production issues promptly, and minimized downtime, enhancing overall efficiency. Production Oversight: Managed and updated Bill of Materials, reviewed production variances, and implemented corrective actions to improve processes. Process Improvement: Identified strengths and weaknesses in production procedures, managed waste, and improved efficiency within production processes. Collaboration: Regularly communicated with Engineering to address issues and ensure seamless operations.In this role, I was able to leverage my leadership skills and technical expertise to optimize production processes, improve efficiency, and maintain high standards of quality.

Temecula, California, United States

As a QC Lead and R&D Technician at Abbot Laboratories, I led quality control efforts and supported research and development for new products. Key responsibilities and accomplishments include: Quality Control Leadership: Led a team of 7 Quality Inspectors, ensuring all inspections met established standards using tools like calipers, gauges, micrometers, and pull testers. Audit Preparation and Compliance: Planned and conducted internal audits to prepare for external FDA QSR audits, ensuring compliance with manufacturing instructions and revising procedures as needed. Production Support: Audited production operators for compliance and documented all inspection results, supporting overall quality assurance. R&D Collaboration: Worked with Engineering on testing and documenting new balloon and catheter products, contributing to the development of innovative medical devices. Daily Operations: Established daily schedules for QC team members, optimizing workflow and productivity.In this role, I utilized my technical skills and leadership abilities to ensure high standards of product quality and support the development of new medical devices.