Quality Technician II - Shockwave Medical

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:
Quality

Job Sub Function:
Quality Control

Job Category:
Business Enablement/Support

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

Job Description:

Johnson & Johnson is hiring for a Quality Technician II​ – Shockwave Medical to join our team located in Santa Clara, CA.

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

Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview
The Quality Technician II provides support to the Design Quality Engineering (DQE) team in daily activities.

This role involves reviewing inspection and test data for adherence to Good Documentation Practices (GDP).

The Quality Technician I must also be able to perform inspections and testing using various measurement systems.

Essential Job Functions:



* Review test and inspection data to ensure compliance with Good Documentation Practices (GDP).


* Audit data collection processes for GDP compliance.



* Perform basic calculations and data analysis.



* Perform Document Change Orders for continuous improvement, or update according to GDP requirements: Data collection forms, Procedures, and Test Methods


* Review test data for accuracy when transferred/transcribed from data collection forms to any statistical or calculation software files for analysis.


* Review inspection and testing reports in accordance with Current Good Manufacturing Practices (cGMP) and maintain inspection and testing files as per established procedures.


* Perform inspection and functional testing of medical device components, tools & fixtures, subassemblies, and finished goods using various measurement systems (e.g., Scienscope, laser micrometer, pin gauges, height gauges, optical instrumentation, Instron, calipers, snap/drop gauges, balloon burst tester, etc.) per specifications or test protocols, and generate Non-Conformance Reports (NCRs) as necessary.


* Conduct functional testing of c...