Staff Quality Engineer Product Dev

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 https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Irvine, California, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

An internal pre-identified candidate for consideration has been identified.

However, all applications will be considered.

We are searching for the best talent for Staff Quality Engineer Product Dev to be in Irvine, California.

Key Responsibilities:


* As part of New Product Development team, contribute to development activities, including design verification test, process validations, and quality processes.


* Serve as subject matter expert on quality lifecycle management and related Quality tools.


* Responsible for revision/approval of engineering drawings for both device components and Tool/Jig/equipment, correct application of GD&T, stack up analysis, etc.


* Develop and establish effective quality control and associated risk management plans.


* Support all Quality Engineering activities for the Life Cycle Management function, including Cost Improvement Projects (CIPs) and Component Qualification activities.

Ensure compliance with the internal quality system policies and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other standards as applicable to medical devices.


* Contribute to quality and process activities for Reliability, Risk Management, Analytics/statistical techniques, Requirements Management, and Verification & Validation.


* Lead quality improvement efforts for legacy products, continuous improvement, and customer satisfaction.

Design or redesign mechanical and thermal devices or subsystems, using computer-aided design, and develop and test prototypes.


* Write, review, and/or approve process and product validation protocols and reports, equipment qualifications, and engineering change orders.


* Use statistical tools to analyze data, make acceptance decisions, and improve process capability, with Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.

Direct Failure Mode and Effects Analysis (FMEA) acti...