HireDiversity

Irwindale, CA, US

QUALITY SYSTEMS & COMPLIANCE SPECIALIST-1931120810

Description

Biosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Systems & Compliance Specialist, to be located in Irwindale, California.

Biosense Webster, Inc., is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes.

The Quality Systems & Compliance Specialist is responsible maintaining and improving a combination of assigned Quality System and Compliance activities that may range from Management Reviews, internal audits, external audits, Quality Review Board Meetings, and coordination of field action/recall activities with FDA and BWI affiliates. Under general supervision, receives general instructions about required tasks and results expected. Work is usually well defined and is checked for progress and reviewed for accuracy upon completion. Applies standard practices and techniques in specific situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.

The Quality Systems & Compliance Specialist is responsible for maintenance and improvement of the quality system. Coordinates the Global Internal Audit schedule, monitors execution and ensures timely completion of observation response and action items. Coordinates internal and external audit preparation, assists during audits and ensures follow-up after audits including coordination of corrective actions for observations. Investigates and develops solutions to procedure and process related issues. Participates on project teams to improve processes within Biosense Webster at either a local or global level. May lead project teams. Assists in the execution and distribution of standard metric ad hoc reports, management reviews, escalation notifications and maintains company Compliance Scorecard and related documentation. Alerts appropriate individuals when specific events or deviations in data are detected.

Functions as the Field Action Coordinator which includes coordinating Quality Hold, Stop Shipment, Products Recalls and Field Corrective Actions. Ensures the receipt of the Field corrective action and Stop shipments by all concerned parties. Ensures delivery of the information to all customers identified through the traceability file via the affiliates. Ensures the reconciliation between the signed customer acknowledgment forms and the traceability files of the Field Corrective Action. Acts as preliminary contacts for other regional Field Action coordinators by responding to questions and providing assistance.

Responsible for following all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Performs other duties assigned as needed. Ensures personal and company compliance with all National and company regulations, policies and procedures for Health, Safety and Environmental compliance. Performs all duties and responsibilities in accordance with any professional requirements as well as those found in applicable policies and procedures and the Credo.

Qualifications


A Bachelor's degree and a minimum of 3 years experience within a Quality environment, or an equivalent combination of education and experience is required. A degree in business, science, or engineering is preferred. Proficiency in the Microsoft Office suite of products is required. Oral and written English proficiency, as well as the ability to complete regulatory reports and provide written correspondence to internal and external customers including regulatory bodies is required. The ability to work in a matrixed, cross-functional environment and effectively balance priorities is required. Knowledge of applicable quality regulations for medical devices, such as ISO13485:2003, FDA's QSRs, EU's MDD, and Canadian Regulations is preferred.

Up to approximately 10% domestic travel may be required. This position will be located in Irwindale, CA.

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Primary Location:North America-United States-California-Irwindale
Organization: Biosense Webster Inc. (6010)