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Sr Quality Engineer, New Product Development (NPD)

Company: Disability Solutions
Location: Irvine
Posted on: April 3, 2024

Job Description:

Biosense Webster Inc, a member of Johnson & Johnson Family of Companies, is recruiting for a Sr Quality Engineer, New Product Development (NPD) to be located in Irvine, CA . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at The Sr Quality Engineer, New Product Development (NPD) , performs quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. 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:

  • Lead and assist in NPD projects.
  • Assist in the development of effective quality control, design verification testing and associated risk documents.
  • Partner with other functional groups, including R&D and Operations in support of engineering projects, quality activities, and lifecycle management.
  • Provide support in quality improvement opportunities as appropriate to legacy products, continuous improvement and customer satisfaction.
  • Understand the corrective and preventive action process and process of investigating nonconformances, identifying root cause and recommending action. Generates nonconformance reports and assists in investigation, final disposition and corrective action.
  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
  • Assigns/reviews quality inspection testing and test data.
  • Supports audits.
  • Review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
  • Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
  • Responsible for communicating business related issues or opportunities to next management levels.
  • Performs other quality related responsibilities as needed.

Keywords: Disability Solutions, Irvine , Sr Quality Engineer, New Product Development (NPD), Engineering , Irvine, California

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