Johnson & Johnson Careers

Senior Quality Engineer

Irvine, California
Quality (Eng)


Job Description

Requisition ID: 3081180927

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 oversees the execution of the quality plan for each product, ensuring product realization is conducted in compliance with internal, customer and regulatory requirements during all phases of the product lifecycle.

Major Duties/Responsibilities include but are not limited to:
  • 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, 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 required or assigned by manager.

Qualifications
Required:
  • Bachelor's degree in a life science, engineering, physical science or related discipline
  • At least 4 years of experience as a quality professional in a highly regulated industry.
  • In-depth knowledge of design control, risk management, production and process controls and applicable regulations (i.e., ISO 13485, FDA Quality System Regulation, ISO 14971)
  • Working knowledge of and experience in the application of statistical methods 
  • Excellent verbal and written communication skills
  • This position to be located in Irvine, CA, and may require 20% travel.

Preferred:
  • Advanced degree in a life science, engineering, physical science or related discipline
  • Process Excellence/Six Sigma certification
  • ASQ Certified Quality Engineer (CQE)
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today. 

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
Organization
Acclarent, Inc. (6206)
Job Function
Quality (Eng)
Requisition ID
3081180927