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Featured Employers
Senior Supplier Quality Engineer
Company: Johnson & Johnson
Location: Irvine, CA
Employment Type: Full Time
Date Posted: 07/31/2021
Expire Date: 11/10/2021
Job Categories: Computers, Software, Engineering, Information Technology, Internet/E-Commerce, Manufacturing and Production, Purchasing, Quality Control, Research & Development, Web Technology, Writing/Authoring
Job Description
Senior Supplier Quality Engineer

Biosense Webster, Inc., a division of Johnson & Johnson’s Family of Companies is recruiting for a Senior 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 Senior Supplier Quality Engineer 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 Senior Engineer will be responsible for external suppliers of direct and indirect materials, finished goods and services for the CSS franchise. They will lead 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 leverage talents and coordinate 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 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. The Senior Engineer 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.

  • Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management.
  • Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management.
  • 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.
  • Prepare Supplier Quality Agreements and drives discussion with supplier
  • Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts

Qualifications
  • A 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 4 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 are desired.
  • Demonstrated ability to identify compliance risks and assess business impact.
  • Ability to manage complexity and work in a diverse team environment 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 disability


Primary Location
United States-California-Irvine-31 Technology Dr
Organization
Biosense Webster Inc. (6010)
Job Function
Engineering
Requisition ID
2105951448W
Contact Information
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