Data Analyst 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:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Data Analyst II - Shockwave Medical to join our team located in Santa Clara, CA.

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/.

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 Data Analyst II will establish, collect, analyze, report, and monitor data and key process metrics related to Quality Management System (QMS) at Shockwave Medical. The general scope of this position will be related to analysis of QMS data and identification of any patterns within the data using statistical control charts, Pareto’s, etc. and utilizing high-quality data presentation skills to ensure information is presented in a clear and concise manner. This role will also provide support as needed for review of quality data for input into various quality metrics/reports within the QMS. This work is accomplished with guidance from management and requires a motivated, self-starter who can work independently.

Essential Job Functions

• Develop and perform effective data analysis and visualization for all elements of the QMS and processes in an accurate and timely manner

• Develop and generate reports and analysis

• Create presentations based on the data sets

• Collaborate with various functional teams to collect and analyze data

• Use graphs, infographics, and other methods to visualize data

• Collect and analyze QMS data for Management Review and other periodic reviews

• Incorporate state of the art data analysis and visualization tools

• Provide support as needed for periodic analysis and review of QMS data such as data for final product release activities, non-conformance system management, CAPA, audits, supplier performance, service order requests etc.

• Support Quality Compliance and Post Market Surveillance activities by extracting and analyzing data to support quality plans/reports, for management review and applicable submissions to regulatory bodies

• Support comprehensive literature searches, review of complaints, CAPAs and adverse events and clinical databases and develop methods to efficiently extract and summarize in a report for Shockwave Medical devices or similar devices

• Assist in establishing Key Performance Indicators (KPIs) to measure effectiveness of the QMS processes

• Identify and develop data points within the QMS processes to enable data analysis and monitoring against key performance indicators

• Assist in monitoring, detecting quality and safety signals associated with product performance, and overall aspects of the Quality