One of my direct client is looking for a QS Specialist I. Contract position. 2012-03-12 to 2012-08-23 Alameda, CA, 94502   Primary Function / Primary Goals / Objectives: The primary function of the QS Specialist I is help ensure that departments responsible for the development, manufacturing, and distribution of products are in compliance with local, divisional and corporate procedures, as well as conforming to the Quality Systems Regulations (21CFR 820), ISO 13485:2003 and other applicable regulations and standards.  Primary goal is to ensure that policies, procedures and processes are in place so that all Quality Systems activities meet applicable regulations. Major Responsibilities 1.     Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site divisional and corporate quality goals and priorities. 2.     Manage policy integration from other site documents into document systems. a. Assists management in the standardization and simplification of documenting processes. This will include the use of flow charts and process mapping tools to ensure connectivity of different processes.  b. Act as primary contact for new releases of corporate policies.  Coordinates for disseminating the new policies to all concerned parties, preparing and coordinating of reviews including minutes, action items, etc c. Compiles the division comments on draft policies and provides consolidated response to corporate. 3.     Quality representative site Training Coordinator: a. Manage and ensure that all training assignments for all quality-system positions are accurate. b. Meet with Training Plan owners and ensure that all required training is noted on Training Plans and ensure they are assigned via ETMS. c. Monitor and track any new documents via Doc Control release for applicability into quality-related training plans. 4.     Corporate AQR/FDA Observation assessment across site:         a. Assists management in monitoring and reporting AQR/FDA observations.         b. Assists management in development of an effective system for aligning and integrating information from AQR/FDA audits.         c. Assist functional areas with assessing and integrating changes in processes and procedures to align with corporate requirements 5.     Management Reviews:         a. Works with QS Director to prepare and conduct required QS Management reviews.  Includes the preparation of the presentation, meeting minutes and follow up on action items. 6.     Audit Readiness key contributor:         a. Acts as primary document controller in audit ready room and ensures all documents are tracked and filed 7.     Assist in the monitoring of ERs and CAPAs for the Quality Systems function as it relates to external audits. 8.     Measures and reports progress against quality goals. Minimum Education Required: This position requires an Associates degree at a minimum. Minimum Experience/Training Required: 3-5 years in a Corporate environment in a support capacity. Knowledge of regulations and standards affecting In Vitro Diagnostics and Medical Devices (CFR 820) (e.g. ISO, FDA Quality System Regulations preferred Candidates will have experience utilizing basic negotiation, influencing and conflict management skills, will interact effectively with peers and leadership across departments and possess excellent interpersonal and communication skills.  Accountability / Scope: This position is accountable for the preparation and reporting of Quality related documentation. Failure to do so would negatively impact the business by inaccurately reporting information required for Management Quality decisions   If interested, please apply to manisha@softpath.net / 510 744 9036