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Senior Quality Engineer
Company: Johnson & Johnson
Location: Irvine, CA
Employment Type: Full Time
Date Posted: 09/25/2021
Expire Date: 12/01/2021
Job Categories: Accounting/Auditing, Engineering, Healthcare, Practitioner and Technician, Installation, Maintenance, and Repair, Manufacturing and Production, Executive Management, Quality Control, Research & Development, Medical
Job Description
Senior Quality Engineer

Acclarent, Inc., part of Johnson & Johnson Medical Devices Companies is recruiting for a Senior Quality Engineer based in Irvine, CA.

Acclarent, Inc., part of Johnson & Johnson Medical Devices Companies, is aligned around a singular focus to free patients to live better lives by designing, developing, and commercializing medical devices that address conditions affecting the ear, nose, and throat. For more than a decade, Acclarent has led the field in delivering innovative technologies to ENT surgeons. For more information, visit www.acclarent.com

The Senior Quality Engineer leads all aspects of the execution of quality plans, ensuring product realization is conducted in compliance with internal, customer and regulatory requirements during all phases of the product lifecycle.  Under limited supervision, general direction, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position is:

  • Reviews new and modified product design and manufacturing processes for quality characteristics, including manufacturability, serviceability, testability, reliability and conformance to product and quality system requirements.
  • Leads the product risk management process, including the development and maintenance of risk management files.
  • Qualifies component and service suppliers, conducts supplier audits and ensures that appropriate supplier quality controls are implemented.
  • Analyzes data and applies knowledge of engineering principles and practices to implement continuous improvement projects.
  • Provides guidance to R&D, Operations and Quality on design and production/process controls, risk management, root cause analysis, validation and the application of statistical methods.
  • Other responsibilities as the need arises or assigned by manager.

  • Bachelor's degree in engineering or physical science with at least 3 years of experience as a Quality Professional in an FDA-regulated industry OR an Advanced degree in engineering or physical sciences with at least 2 years of experience as a Quality Professional in an FDA-regulated industry is required
  • At least 2 years in the Medical Device industry is preferred
  • Knowledge of design control, risk management, production and process controls and regulations (i.e., ISO 13485, FDA Quality System Regulation, ISO 14971) is required
  • Solid understanding of and experience in statistics is required
  • Excellent verbal and written communication skills and the ability to effectively connect with internal and external personnel
  • Process Excellence/Six Sigma certification is preferred
  • ASQ Certified Quality Engineer (CQE) is preferred
  • Up to 20% travel 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

Primary Location
United States-California-Irvine-31 Technology Dr
Acclarent, Inc. (6206)
Job Function
Requisition ID
Contact Information
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