Quality Systems Specialist

Breathe Life Into Your Career Respironics, a worldwide leader at anticipating needs and providing valued solutions to the sleep and respiratory markets. The company's focus is on home care, hospital, respiratory drug delivery and international markets providing programs that manage sleep disordered breathing, chronic obstructive pulmonary disease, asthma, infant care, congestive heart failure and restrictive lung disorders. Globally positioned has manufacturing facilities in several domestic and international markets. We have an immediate opportunity in our Pittsburgh, PA territory for:Quality Systems SpecialistResponsibilities: Develop a training plan for annual Quality Systems training for all S&HR associates and work with the appropriate functional area leaders to conduct this training as planned. Develop and execute a training plan for focused training as needed for functional areas. Ensure that these training plans are comprehensive and in accordance with the requirements of FDA's Quality System Regulation (21 CFR Part 820), ISO 9001:2000, ISO 13485:2003, EU Medical Device Directive (MDD), and the Canadian Medical Device Regulation (CMDCAS). Ensure that the training includes an evaluation of the competence of associates and a measurement of the effectiveness and impact on the organization. Partner with Human Resources and conduct Quality Systems training for new associates as needed and ensure job descriptions for associates are developed, controlled, maintained, and readily available. Partner with Human Resources, Operations, Service, Distribution, and other functions to provide ongoing quality systems training for career path and non-career path associates as needed and assist with ensuring the necessary level of competence for the effective and efficient operation of the organization. Team with functional areas to ensure training records are maintained for associates as required. Team with other Groups, i.e. Hospital Group and International Group, to ensure best practices for quality systems training are implemented. Participate or assist in internal audits and external audits (Notified Body, FDA, customers, etc.) as needed. Lead efforts to update the S&HR Quality Manual as required. Execute the annual QSP / WI (SOPs) review process and ensure that process owners identify and implement necessary changes to their SOPs. Execute approvals in SAP as Quality representative for SOP changes as required. Develop and implement a Data Analysis SOP for the Quality System. Work with appropriate functions within S&HR to ensure there is an effective process in place to satisfy the requirements for Medical Device Tracking in accordance with 21 CFR Part 821. Ensure the process includes tracking, recording, and auditing of tracked devices. Perform various Quality Systems activities on an as-needed basis to support business needs (preparation of quality management review data, support field action activities, etc.) Requirements: # B.S. or B.A. in Engineering, Life Sciences or other similar technical field. Extensive knowledge and experience in Quality Systems training, specifically 5 or more years of experience implementing and/or executing training processes in a regulated environment. Knowledge of the GMP regulations and quality standards. Good judgment and decision-making. Planning and organization skills. MS Office applications; SAP preferred.At Respironics Inc., our products improve the lives of patients with a variety of respiratory needs in the hospital, homecare, critical care and neonatal environments. To learn more about our organization, our products and our culture...please apply online and reference job number: 1855BR.Your interest in our company is appreciated however, only candidates considered for interview selection will be notified. AA/EOE.www.respironics.com Apply Online: https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=25012&siteid=5146&AReq=1855BR&Codes=MON