Susan R.

Susan R. has over twenty-eight years of experience in the quality assurance field. Susan began their career in 1993 as an Administrative Assistant/Merchandising Assistant at Chadwick's of Boston. In 1996, they became a Lead Quality Auditor at Shawmut Corporation, where they developed and maintained the internal auditing system in accordance to the ISO9001 and TS16949 quality standards, trained internal quality auditors, and maintained the Customer Complaint, CAPA, NCR and RMA databases. In 2008, Susan moved to Millstone Medical Outsourcing as a Quality Engineer, where they developed and executed validation protocols and final reports (IQ, OQ and PQ). Susan also packaged medical implants (pouch and tray configurations) within a Class 10,000 Clean Room environment. In 2011, Susan became a Quality Engineer at Primo Medical Group (formerly STD Med), where they generated and executed validation protocols and final reports (OQ and PQ), developed the label department by redesigning and controlling all in-house and customer-owned product labels, and developed, revised and implemented work instructions through the ECO system. In 2012, Susan took on the role of Quality Systems Manager at Epec Engineered Technologies, where they developed, maintained, and managed the Quality Management System for two facilities, developed the auditing program and document control system within NetSuite, and developed, maintain, and manage the internal and external quality audit system, calibration, CAPA, and document control systems. In 2019, they joined Integra LifeSciences as a Sr. Quality Systems Engineer, where they oversaw the effective implementation of the QMS, including business accreditations (MDSAP certification), maintained site Quality Manual and Quality Procedures, organized both front and back rooms for external registrar audits (MDSAP), and hosted external registrar Quality Systems audits. Susan currently holds the role of Quality Assurance Manager at Beeken Biomedical.

Susan R. received an A.S. in Business Management from Newbury College between 1992 and 1995. Prior to that, they obtained an Associate of Science (A.S.) in Business Administration and Management, General from Massasoit Community College between 1985 and 1987. Additionally, they have an ASQ CERTIFIED QUALITY AUDITOR certification from ASQ.