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Senior Supplier Quality Development Engineer

Company: Johnson & Johnson
Location: Irvine
Posted on: November 25, 2022

Job Description:

Job Description - Senior Supplier Quality Development Engineer (2206076301W) Senior Supplier Quality Development Engineer - 2206076301W Description Biosense Webster, a member of the Johnson & Johnson family of companies, is recruiting for a Senior Quality Engineer New Product Development(1 of 2), located in Irvine, CA area.Biosense Webster, Inc. (BWI) is the global leader in the science of diagnosing and treating heart rhythm disorders. BWI is part of the Cardiovascular and Specialty Solutions Group (CSS) of Medical Device sector of Johnson and Johnson. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. For more information, visit www.biosensewebster.comThe -Senior -Supplier Quality -Engineer -(Sr. 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 Sr. 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 -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. She/he 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.If you are and individual who enjoys working with the other team members and changing the lives of our patients around the world come join our team at Biosense Webster!Key Responsibilities:

  • 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 support the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management. May lead this process under the guidance of Supplier Quality -Manager and/or management representative.
  • 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.
  • Develop/execute -Quality Risk -Management -process -for -supplier-related -matters with -partnerships of -subject-matter experts
  • Understand or anticipate the customer's needs and adds value by providing specific metric information tailored to the business environment.
  • 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
  • Respond proactively to changing regulatory and business needs
  • 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 minimum of a Bachelor's degree in Engineering, an Applied Science or a related technical and quality field is required. -
    • A minimum of 4 years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required.
    • Knowledge of manufacturing principles and practices, and procedures is required
    • Component Qualification/Process Validation experience is required
    • Manufacturing, plant or technical background - preferred
    • Working experience in good manufacturing practice regulated industry (medical device, pharmaceutical, etc.). - preferred
    • Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls is preferred
    • Documentation and technical writing skills, in a regulated compliance environment is preferred
    • New product introduction experience is desired.
    • Prior experience with FDA inspections is desirable.
    • Demonstrated ability to identify compliance risks and assess business impact is preferred.
    • 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.
    • Ability to travel up to 10% for local, domestic or international business support is required. 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. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor 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.andEqual Employment Opportunity Posters GINA Supplement. If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance This site is governed solely by applicable U.S. laws and governmental regulations. Please see our. Use of this site constitutes your consent to application of such laws and regulations and to our. Your use of the information on this site is subject to the terms of our. You should view thesection and the most recent SEC Filings in thesection in order to receive the most current information made available by Johnson & Johnson Services,Inc.with any questions or search this site for more information.Privacy Policy Privacy Policy Legal Notice News Investor Contact Us

Keywords: Johnson & Johnson, Irvine , Senior Supplier Quality Development Engineer, Engineering , Irvine, California

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