Johnson & Johnson Careers
Senior Quality Engineer
Requisition ID: 5979190329
Johnson & Johnson's Family of Companies is recruiting for a Senior Quality Engineer to be located in Irvine, CA to support our Acclarent business.
Chronic sinusitis affects 3 million Americans each year and five per cent of the U.S. adult population suffers from a phenomenon referred to as Eustachian Tube Dysfunction (blocked ears / ear pain). Acclarent, Inc. is dedicated to supporting otolaryngologists with minimally-invasive ENT technologies that relieve this suffering as effectively and painlessly as possible. For more than a decade Acclarent, Inc. has pioneered innovative technologies, including the balloon dilation system that’s been used to treat more than one million patients.
You, the Senior Quality Engineer handles the execution of the quality plan for each product, ensuring product realization is in compliance with internal, customer and regulatory requirements during all phases of the product lifecycle.
Major Duties/Responsibilities include:
•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.
•Manages the product risk management process, including the development and maintenance of risk management files.
•Qualifies component and service suppliers, and ensures implementation of supplier quality controls.
•Analyses data and applies knowledge of engineering principles and practices to implement continuous improvement projects.
•Provides feedback 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 required or assigned by manager.
•Bachelor's degree in an engineering discipline required.
•Minimum of 3 years of professional experience in a highly regulated industry required.
•In-depth knowledge of design control, risk management, production and process controls and applicable laws (i.e., ISO 13485, FDA Quality System Regulation, ISO 14971) preferred.
•Working knowledge of and experience in the application of statistical methods preferred.
•Requires the ability to 20% travel international and domestic.
•Process Excellence/Six Sigma certification preferred.
•ASQ Certified Quality Engineer (CQE) preferred.
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.
Acclarent, Inc. (6206)