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Biosense Webster, Inc., a division of Johnson & Johnson's Family of Companies is recruiting for a Staff Supplier Quality Engineer located in Irvine, 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 Staff Supplier Quality Engineer (Staff SQE) provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products. The Staff SQE will be responsible for external suppliers of direct and indirect materials, finished goods and services for the CSS franchise. He/she leads the deployment of the Supplier Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the CSS supply chain.This individual will actively leverage talents and lead teams (SQEs and others), collaborate with Strategic Sourcing/Procurement, R&D, Engineering/Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve suppliers’ quality and overall service and performance. In this role, the individual supports the development and execution of plans/strategies, and implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regards to the determination, selection, qualification, monitoring, and disengagement of suppliers. This person will proactively identifies, develops, and leads the investigation and resolution of supplier-related challenges, and implements appropriate Quality Engineering methodologies, statistical techniques, process capability analyses/improvements, DOE/process optimization, and other technical or Process Excellence (PEx) tools in support of supplier-related changes, risk management, product/process transfers, innovations, and continuous process enhancements to improve supplier reliability, minimize risks, and ensure sustainable sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements.DUTIES & RESPONSIBILITIESUnder limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:Provide timely business support for the assigned CSS Supplier Quality Management (SQM) function globally
Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management.
Participate in and/or lead the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management.
Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.
Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.
Utilize analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Worldwide Supplier Quality Management Team.
Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Lead discussions to drive resolution.
Collaborate with operations and franchise operations development on process/product improvement projects.
Prepare Supplier Quality Agreements and drives discussion with supplier while consulting Supplier Quality Manager.
Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts
Own and lead the Supplier Quality Relationship Management (SQRM) process for the assigned suppliers (e.g. Lead periodic SQRM meetings including supplier quality performance reviews, supplier investigation follow-ups, investigation responsiveness/cycle time, targeted improvement plans (TIP), closed loop corrective actions, NC reductions, supplier quality metrics, etc.).
Understand or anticipate the customer’s needs and adds value by providing specific metric information tailored to the particular business environment.
Take actions to identify internal customer requirements and translate customer requirements into potential proactive improvements to components or supplier quality systems. Proactively pursue clarification to confirm understanding of internal customer needs and requirements. Follow up on commitments and keeps customer, management and appropriate parties apprised.
Respond proactively to changing regulatory and business needs.
Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.
Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements
Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).
Responsible for communicating business related issues or opportunities to next management level
For those who supervise or manage a staff, 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, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
QualificationsA minimum of a Bachelor's degree is required. Degree in Engineering, an Applied Science or a related technical and quality field is preferred.
A minimum of 6+ years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required.
Prior manufacturing, plant or technical background is required.
Working experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.).
Demonstrated knowledge of manufacturing principles and practices, and procedures.
Direct experience in plant and/or supplier GMP auditing is preferred.
Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls.
Experience with documentation and technical writing skills, in a regulated compliance environment, is required.
Component Qualification/Process Validation experience is preferred. New product introduction experience is desired.
Prior experience with FDA inspections is desirable.
Broad knowledge of Quality System Regulations and Supplier Quality Management principles is desired.
Demonstrated ability to identify compliance risks and assess business impact.
Ability to manage complexity and lead a diverse team is essential.
Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches.
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 disabilityPrimary LocationUnited States-California-Irvine-31 Technology DrOrganizationBiosense Webster Inc. (6010)Job FunctionEngineeringRequisition ID2105885548W
