Sr Quality Engineer

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:
R&D Product Development

Job Sub Function:
R&D Mechanical Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
San Jose, California, United States of America, Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is recruiting for a Sr.

Quality Engineer, located in Santa Clara, California.

This is a fully onsite position.

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/.  

Our Design and Sustaining Quality team advances the MONARCH™ surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products.

We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes and advance medical professionals’ skills.

Key Responsibilities:


* Support product requirements, risk management, verification strategies, validation strategies, and quality audits.


* Collaborate on, review, and approve design, manufacturing, quality, engineering, and validation / qualification documentation.


* Collaborate cross-functionally with, including but not limited to, Quality, R&D, Supply Chain (including Manufacturing), Regulatory Affairs, Marketing, Clinical Affairs/Research.


* Develop, revise, and apply quality system procedures.


* Drive prevention and detection of defects at earliest phase of product design, continuous improvement, and customer satisfaction.


* Investigate and resolve product and quality system nonconformances.


* Provide recommendations on statistical analysis and analytical problem solving for product development.


* Lead and execute design and quality projects.


* Ensure compliance with GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and other applicable standards and regulations.


* Guide contractor personnel in achieving deliverables.

Qualifica...