Ensure compliance and continuously improve/Standardize purchasing controls process at assigned sites to corporate and external requirements. Coordinate and lead purchasing controls activities as front room SME and backroom support during internal/external audits. Provide guidance on new supplier classifications, additions, and ASL maintenance. Set-up/oversee a compliant and streamlined process for ASL management at assigned sites. Create and manage Trackwise SAM records. Contribute to global purchasing controls procedure updates and support implementation at affected local sites. Lead the annual Quality Performance Review for supplier scorecards within defined deadline and tracking resulting actions thru to completion. Consulting with M&A on Purchasing Controls activities to support successful integration. Actively participate in the Purchasing Controls Hub and Spoke meeting to enhance processes and share best practices. Support assigned site NC/CAPAs for purchasing controls.

Senior RA/QA Consultant for EMERGO, focusing primarily on the US and EU markets offering a wide range of services including QMS auditing/implementation, quality compliance, biocompatibility, and sterilization support.

Assessing non-active medical devices such as hip, knee, shoulder joint replacement, and spinal devices, as well as their manufacturers by utilizing the knowledge of the European Medical Devices Directives, other applicable regulatory requirements, and recognized standards such as ISO 13485 and ASTM standards.Performing regulatory audits of clients per European Medical Device Directives, Canadian Medical Device Regulations, Japanese Pharmaceutical Affairs Law and International quality system standards specifically ISO 13485, as well as internal Notified Body and TÜV SÜD America criteria. Reviewing Quality System related tasks, such as management, design and development, corrective actions; as well as preparing reports and audit documentation for submission to the certification committee of the Notified Body.Performing evaluations of product regulatory submissions including: Design Dossiers (Class III) and Technical Files (Class II), according to European Medical Device Directives.

Effectively managing reprocessing cleaning and sterilization validation activities in support of all new products or sustaining product changes. New Product sterilization representative responsible for successfully adopting new products to the sterilization product family or coordinating validation testing as needed to support regulatory requirements (ISO 11137, ISO 17665, and ISO 14937). Working with multiple cross-functional teams to support team deadlines for product release.Biocompatibility specialist for new material evaluations, determining and coordinating testing to support the use of new materials in instrument and implant products in accordance with ISO 10993. Reviewing process changes to existing products to ensure continued biological safety. Managing the environmental monitoring program at DJO Surgical and ensuring compliance to ISO 14644. Sustaining product sterilization representative responsible for remediation and improvement activities identified for legacy products. Managing CAPAs, HHEs and improvement projects to facilitate remediation. Maintaining sterilization compliance by performing dose audit activities in accordance with ISO 11137 and H2O2 gas plasma sterilization requalifications per ISO 14937. Performance of on-site H2O2 Gas plasma validation and re-validations including performance of manual peroxide delivery to the STERRAD NX system. Instrument reprocessing Liaison to hospital central sterile departments seeking information about cleaning and sterilization information for reusable orthopaedic instruments. Subject Matter Expert (SME) for Sterilization, Reprocessing, Cleaning, Biocompatibility, Environmental monitoring.Sterilization – Gamma, Moist heat, and H2O2 Gas plasma Lead internal auditor coordinating and conducting internal audits to ensure compliance to both external regulatory standards (ISO 13485) and internal procedures.Software experience- Microsoft, Sharepoint, ComplianceWire, Agile, Oracle