- Design, implement, and maintain a comprehensive Quality Management System (QMS) in line with ISO 13485, ISO 14971, and other applicable regulatory standards tailored to the needs of a small tech business.- Monitor and interpret relevant SaMD regulations and standards to ensure compliance.- Lead the development and implementation of Design Controls, Design Verification & Validation and Risk Management activities.- Manage external audits and inspections by regulatory bodies and customers.- Lead root cause analysis and corrective/preventive action processes.- Develop and deliver training programs to ensure that all employees are aware of and understand their responsibilities within the QMS.

Execute quality activities for surgical blade manufacturing. Conduct root cause analysis and implemnent corrective actions for manufacturing issues, coordinate with cross-functional team for new product introduction. Implement changes to the Quality Management Systems to modernize quality practices.•Updated FMEA procedures to align with ISO 14971:2019 and re-executed PFMEAs throughout the entire manufacturing process to meet current best practices•Performed 6 Internal Audits in the first 2 months to close gaps prior to ISO 13485re-certification audit.

Manage customer complaints for medical and pharmaceutical Tyvek. Identify process improvements based on customer feedback and implement solutions which improve quality to our customers. Provide a customer focused approach to product and process changes. Lead implementation of improved FMEA and Validation procedures. Develop data visualizations using Tableau for company-wide visibility of quality metrics. Conduct internal and external audits.

Quality Engineering: component qualification, risk management, non-conforming material investigation and disposition, design control, inspection techniques, internal auditing, etc in the Medical Device industry.Quality Control Supervisor: Prioritize inspection activities, review inspection reports, manage Quality Control inspectors, oversee gage control & calibration, control non-conforming material

Quality Engineering including non-conforming material investigation/disposition, risk management, assembly process development and qualification in Consumer Goods industry.

Quality Engineering including component qualification, validation, risk management, non-conforming material disposition, CAPAs, customer complaint investigation, inspection techniques, etc in the Medical Devices industry.