laurie bruner

* Responsibilities include management of the Acute Care complaint handling group * training associates on current quality policies and practices * coaching and supervision of team members * submission of MDRs and standardizing reporting activities * writing standard operating procedures and work instructions * CAPA investigation and implementation * interfacing with regulatory bodies and auditors including the FDA and ISO * working with other organizations within Hill-Rom to improve processes surrounding complaint handling

Responsibilities include production support, both assembly and plastic injection molding, identification and reduction of process variation, writing and approving standard operating procedures and quality inspection plans, interfacing with regulatory bodies and auditors including the FDA and ISO as Deputy Management Representative; providing all employees with Quality System training and providing specific job related training within the Quality department; dispositioning of nonconforming material as part of the Material Review Board (MRB) and management of the MRB system; management of: the internal audit program and CAPA program, managed/coordinated implementation of process validation system (IQ, OQ, PQ)

* Site level QA leadership. Management of Failure Investigation, Document Control, Quality Engineering, Calibration, Internal Audit, Supplier Management, Post-Market Vigilance and Incoming Inspection functional areas. * Introduced visual metrics in all areas of the plant * Reduced Failure Investigation cycle time from an average of >100 days to <7 days * Implemented a risk-based nonconformance program * Quality lead on several successful product transfers into the plant * Management Representative

* Site level QMS leadership. Managed the CAPA program, document control, internal audits, management review, complaint handling; coaching and supervision of team members; submission of MDRs and standardizing reporting activities; managed of post-market field actions including recalls. * Reduced the number of open CAPAs from >100 to 25 and implemented a risk-based approach to CAPA * Achieved lifting of an existing warning letter as SME on CAPA and complaint handling * Instrumental in avoiding escalation of additional FDA 483 findings to warning letter status * Improved relationships with key customers through communication and metrics

* Raytheon Company is a technology and innovation leader specializing in defense, security and civil markets throughout the world. With a history of innovation spanning more than 90 years, Raytheon provides state-of-the-art electronics, mission systems integration and other capabilities in the areas of sensing * effects * and command, control, communications and intelligence systems * as well as a broad range of mission support services.This is Raytheon's official company LinkedIn page. View our social media page participation guidelines: http://rtn.co/RTNSocialGuidelines

* Site level QA leadership. Management of document control, internal audits, CAPA, risk management, complaint handling, nonconformances and supplier approval and development activities at our contract manufacturers. * Implemented the Quality Management System for a device start-up company * Achieved ISO 13485 certification within seven months * Led Quality initiatives such as QMS software implementation and QMS alignment with other Regentec sites * Improved the process for partnering with and approving contract manufacturers * Management representative.