Johnson & Johnson Careers
STAFF QUALITY ENGINEER
Requisition ID: 8922190522
Johnson & Johnson's Family of Companies is recruiting for a Staff 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 Staff 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.
The Staff Quality Engineer leads the execution of the quality plan for each product, ensuring product realization in compliance with internal, customer and regulatory requirements during all phases of the product lifecycle.
* 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 for specific product lines.
* Qualifies component and service suppliers, conducts supplier audits and driving improvements to supplier controls
* 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 required or assigned by manager.
* Bachelor's degree in engineering (preferably Mechanical, Electrical or Biomedical) required, advanced degree preferred
* At least 6 years of experience as a Quality Professional in an FDA-regulated industry or at least 4 years in the Masters or higher education required
* In-depth knowledge of design control, risk management, production and process controls required
* Working knowledge of and experience in the application of statistical methods required
* Experience with New Product development from a quality, Product Management or R&D function required
* Excellent verbal and written communication skills and the ability to effectively communicate with internal and external personnel
* Process Excellence/Six Sigma Certification (Black Belt) preferred
* Certified Quality Engineer preferred
* Up to 20% Travel required for this position, both domestic and international
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)