MANAGER, SUPPLIER QUALITY Job in Irwindale, California US
Biosense Webster, Inc (BWI), a member of Johnson Johnson's Family of Companies, is recruiting for a Manager, Supplier Quality, 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 Manager, Supplier Quality plans, manages and coordinates quality assurance activities designed to ensure effective supplier quality management processes are in place and consistent with established standards by performing the following duties personally or through subordinates.
The Manager, Supplier Quality assists in the development and implementation of departmental strategies, procedures and services for supplier quality management and product quality assurance of Supplier externally manufactured products and components. Establishes and implements a quality strategy for internal and external manufacturing to ensure external supplier and contract manufacturing/packaging and testing support services. Manages the supplier strategy and relationship to ensure that compliant systems and procedures are in place from development through commercialization, including the supplier selection and approval process. Establishes quality metrics and measures/trends performance to established CTQs for Biosense Webster suppliers. Drives the timely investigation and resolution of product and process non-conformances for external manufacturers and suppliers. Supports 3 rd party assessments at supplier locations as needed. Interacts with the JJ MDD Quality and Supply Chain organizations as needed, relative to supplier quality management initiatives, projects, Sector-driven requirements and issue resolution (problem identification, root cause analysis, corrective action, product disposition, etc.).
This individual partners with the Strategic Sourcing, Global Supply Chain and MDD Supplier Quality Management organizations to manage supplier quality and performance activities. Works closely with suppliers to promote Six Sigma and Process Excellence activities. Develops, negotiates, and ensures execution of Quality standards for externally manufactured products and components. Provides trend analysis for future internal manufacturing and outsourcing business strategy. Helps resolve supplier quality and other performance issues, as needed. Supports internal audits and 3 rd party audits of supplier facilities and locations as needed. Manages subordinate personnel and their teams, and is responsible for the activities, coordination and evaluation of these individuals. Manages and controls department budget. Responsible for communicating business related issues or opportunities to next management level. 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 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 related field of study and a minimum of 5 years experience as a Quality Professional in the Medical Device or other regulated industry is required. A Master's degree is preferred. A minimum of 2 years prior supervisory or leadership experience is required. The ability to make solid decisions that will effectively support the Quality and Compliance organization and company policies is required. Superior knowledge of quality and manufacturing systems and processes and applicable regulations is required. The ability to apply project management skills to ensure fulfillment of long-term requirements is required. Demonstrated analytical and problem solving skills are required. At least a moderate understanding and demonstrated use of PE/Six Sigma tools and methodologies is required.
The ability to work in a global fast paced environment with rapidly shifting priorities is required. Working knowledge and experience in managing 3 rd party inspections and negotiating with 3 rd parties on compliance issues is required. The ability to influence without direct authority is required. Good verbal and written communication skills and the ability to effectively communicate with internal and external personnel at all levels of the organization are required. Experience training employees is preferred. CQM or CQE certification from the American Society for Quality (ASQ) or equivalent is preferred. The ability to prepare presentations and broad communications is required. Proficiency in the Microsoft Office suite of products and familiarity with statistical tools and methods is required.
Up to 30% international and domestic travel may be required. This position will be located in Irwindale, CA.
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