HireDiversity

Irwindale, CA, US

Director Worldwide Quality Systems-2485120815

Description

Biosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Director Worldwide Quality Systems, 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 Director Worldwide Quality Systems is responsible for planning and implementing the WW Quality Systems strategy including complaint handling and analysis, documentation, training, organizational planning, implementation of technology, and developing and implementing tactical plans to meet Company and Corporate objectives. This individual implements policies to ensure compliance with applicable US Federal and applicable WW regulations. Plans, coordinates, and directs WW Quality Systems to ensure products are consistent with established standards by performing the following duties personally or through subordinates.

The Director Worldwide Quality Systems plans and directs resources and activities of the Worldwide Quality System functions related to Complaints Management, Document Control, Labeling and Training. Designs and develops procedures and processes for recording, evaluating, and reporting quality and reliability data associated with the Quality Systems. Cooperates with other top management personnel in formulating and establishing worldwide company policies, procedures, and quality objectives. Develops initial and subsequent modifications of quality assurance activities to delineate areas of responsibility, personnel requirements, and procedures. Evaluates contents of reports from Quality System processes, quality assurance department heads and confers with top management personnel in preparation of business planning for quality assurance. Conducts management meetings with department heads to establish, delineate, and review organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining quality objectives. Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures. Monitors field complaints and quality systems data. Ensures proper data transformation into thorough information and metrics. Brings those in need of corrective and preventive action to upper management's attention. Assures implementation of corrective and preventive action as required and maintains documentation accordingly. Assures appropriate processes are in place to file and report MDRs/MDVs in a timely manner and per requirements of each region. Estimates budget for Quality System departments and maintains operating costs within constraints of those budgets. Manages subordinate managers, is responsible for the overall direction, coordination, and evaluation of these departments.

The Director Worldwide Quality Systems carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Ensures a technical liaison between Compliance, R&D and Operations in terms of product objectives, with respect to Quality System processes. Ensures that Quality System resources are capable of providing required consultation and input for new projects, manufacturing and distribution. Provides updates to Johnson & Johnson MD&D Sector and Supply Chain regarding Quality System status and performance as it relates to Quality System activities. Advises staff to help meet established schedules or resolves technical or operational problems. Maintains an up-to-date knowledge in the techniques of quality, and in the company products and process technologies. Maintains up-to-date knowledge of FDA, ISO 13485 and MDD regulations as well as all other applicable worldwide standards and requirements. Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety, and Environmental practices and that all resources needed to do so are available and in good condition. Supports company goals and objectives, policies and procedures, quality systems, and FDA regulations/MDD/ISO and other regulatory requirements. Responsible for ensuring subordinates follow 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 communicating business related issues or opportunities to next management level. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Performs other duties assigned as needed.

Qualifications


A Bachelor's degree in a scientific and/or engineering discipline or related area of study and a minimum of 8 years experience as a Quality Professional in an FDA regulated industry, with at least 5 years of Medical Device industry experience is required. A Master's degree is preferred. A minimum of 5 years of prior supervisory experience is required. Process Excellence/ Six Sigma certification is a plus. In-depth knowledge of quality and manufacturing systems and processes and applicable regulations, i.e. ISO 13485, FDA's GMP and QSR requirements for medical devices is required. Practical knowledge of Quality Systems is required.

Superior verbal and written communication skills and the ability to effectively communicate with internal and external personnel at all levels of the organization is required. Working knowledge and experience in managing third party inspections and negotiating with 3rd parties on compliance issues is required.

Up to approximately 20% domestic and international travel may be required. Weekend travel and work, and participation in conference calls and meetings during late night/early morning hours may be required occasionally. This position will be located in Irwindale, CA.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

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