Johnson & Johnson Careers
SUPPLIER QUALITY ENGINEER II
Requisition ID: 0265190325
Biosense Webster, Inc. is currently recruiting for Supplier Quality Engineer II, to be located in Irwindale, CA.
Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
The Supplier Quality Engineer II participates in, supports and leads activities related to the suppliers of raw material, components, finished goods and services for the receipt inspection of the materials, such as the implementation of corrective and preventive actions, rating, validation and certification, as well as to perform quality improvement projects.
This position will have responsibilities across ETHICON and Cardiovascular and Specialty Solution (CSS) Companies Johnson and Johnson Family of Companies) including a span of multiple product platforms such as General Surgical Devices, Sutures, ENT, Infection Prevention, Electrophysiology and Surgical and Non-Surgical Aesthetics.
DUTIES & RESPONSIBILITIES
Under supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
· Participates in, attends, and generates data for quality metrics meetings and others to which he/she is required.
· Provides support to the different departments when it comes to monitoring situations regarding supplier quality.
· Provides support to the receipt inspection group (technician, group leader, supervisor, etc.) in the decision making and the monitoring of non-conforming material of the supplier.
· Responsible for the monitoring of the investigations with suppliers, related with non-conformant materials.
· Provides support to the supplier in research and continuous improvement techniques.
· Responsible for generating corrective and preventive actions to the supplier and verifies the implementation and effectiveness of the actions, obtains the approval and closing.
· Responsible for answering, implementing and closing corrective and/or preventive actions, internal as well as external.
· Leads and supports supplier development initiatives to reach their certification and eliminate or reduce the receipt inspection.
· Participates in supplier rating, validation and certification process, inspection methods and equipment.
· Participates in the analysis and monitoring of customer complaints regarding raw materials, components, finished goods of the supplier or services when required.
· Complies with the regulations of the company, local, state and federal, as well as with security, health and environmental procedures.
· Participates in Kaizen, PE (GB/BB) and Lean projects.
· Interacts with other groups of the organization in the development and selection of suppliers.
· Provides support to the supplier quality audit group by providing information about the performance of the suppliers or in the risk assessment when required.
· Visits and evaluates suppliers through the execution of audits or suppliers’ technical evaluation, when required.
· Participates in the introduction of new products in regard to new components and suppliers.
· Leads and participates in the changes required by the suppliers (material, process, methods, systems, transfers, etc.) jointly with other areas of the organization.
· Participates in the research, presentation and risk assessment of non-conformant components of suppliers.
· Responsible for escalating exceptions of suppliers in the specifications.
· Responsible of generating, revising and approving changes in the procedures, work instructions, specifications, inspection reports, etc. in the changes system of the organization, related to suppliers or with the process of management of quality of suppliers.
· 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.
· Bachelor’s degree in engineering or equivalate work experience required.
· 3 years of experience in quality, supplier quality, or working in a regulated industry preferred.
· Knowledge of system of corrective and preventive actions.
· Knowledge of statistics analysis and problem-solving techniques.
· Basic knowledge of project management tools.
· Knowledge of GMP, QSR, ISO 13485 required
· Experience in the development, validation, certification and audit of suppliers.
· Management of drawings and specifications as well as of departmental procedures.
· Knowledge of document control systems. Preferably JDE and cPDM.
· Use of computer and general MS Office programs.
· Ability to work self-directed and be organized with supervision.
· Abilities to take actions based on the J&J CREDO.
· Understanding of basic business principles.
· Availability to travel up to 25%.
· Desirable certification as Green Belt.
· Desirable certification as CQA or CQE (by ASQ).
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Biosense Webster Inc. (6010)