Associate Complaint Investigator open to new opportunities
Align Technology Inc
Lead product complaint investigations, ensuring timely updates to stakeholders and conducting risk assessments to prevent further customer impact and mitigate company liabilities.. Delivered quality training to new associates, preparing them for audits and fostering a culture of continuous improvement. Led meetings, presented findings, and guided peers toward successful outcomes through positive and goal-oriented leadership.. Trained as an internal auditor with strong knowledge of ISO 13485:2016, FDA regulations, and MDSAP standards. Proficient in root cause analysis tools, KPIs, and quality management systems.. Collaborated on cross-functional projects with RTTs, clinical teams, and technicians to enhance workflows, communication, and quality standards. Provided constructive feedback and demonstrated strong problem-solving and protocol adherence.. Successfully managed global process transitions, including mapping sessions and training across international teams. Skilled in leading virtual meetings and achieving results in multicultural environments.
Align Technology Inc
Executed 3D dental treatment setups using specialized software, consistently meeting production targets and adhering to company protocols.. Provided technical support and guidance to fellow technicians, resolving issues and managing case assignments across regions. Monitored production quality and technician performance.. Participated in software pilot testing, offering valuable feedback to optimize system functionality and user experience.. Delivered outstanding customer service by actively listening to client needs, resolving concerns, and ensuring satisfaction through clear and empathetic communication.
Align Technology
Support Quality Management System (QMS) activities within the medical device industry, ensuring compliance with internal procedures and applicable regulatory requirements.. Develop, review, maintain, and support execution of Quality Plans throughout product and process lifecycles.. Manage controlled documentation, quality records, and change requests through Arena QMS, ensuring document accuracy, traceability, and compliance.. Partner with cross-functional teams including Quality, Engineering, Operations, Regulatory Affairs, and Project Management to support quality and compliance initiatives.. Participate in CAPA activities, root cause investigations, risk assessments, and continuous improvement projects to strengthen quality performance and process effectiveness.. Support internal audits and quality system assessments while contributing to organizational audit readiness efforts.. Ensure compliance with ISO 13485, MDSAP, FDA regulations, and internal quality standards through documentation review and quality oversight.. Contribute to process improvement initiatives by identifying opportunities to increase efficiency, standardization, and quality system effectiveness.. Develop and leverage Artificial Intelligence solutions, AI agents, prompt engineering techniques, and workflow automation tools to improve documentation management, operational efficiency, and knowledge sharing.. Collaborate with global stakeholders and cross-functional teams to support successful project execution and quality objectives.. Recognized for strong analytical skills, attention to detail, problem-solving capabilities, and a proactive approach to quality and compliance.
Align Technology
Lead product complaint investigations, ensuring timely updates to stakeholders and conducting risk assessments to prevent further customer impact and mitigate company liabilities.. Delivered quality training to new associates, preparing them for audits and fostering a culture of continuous improvement. Led meetings, presented findings, and guided peers toward successful outcomes through positive and goal-oriented leadership.. Collaborated on cross-functional projects with RTTs, clinical teams, and technicians to enhance workflows, communication, and quality standards. Provided constructive feedback and demonstrated strong problem-solving and protocol adherence.. Successfully managed global process transitions, including mapping sessions and training across international teams. Skilled in leading virtual meetings and achieving results in multicultural environments.
Align Technology
Executed 3D dental treatment setups using specialized software, consistently meeting production targets and adhering to company protocols.. Provided technical support and guidance to fellow technicians, resolving issues and managing case assignments across regions. Monitored production quality and technician performance.. Participated in software pilot testing, offering valuable feedback to optimize system functionality and user experience.. Delivered outstanding customer service by actively listening to client needs, resolving concerns, and ensuring satisfaction through clear and empathetic communication.
Bachelor's Degree