Function
Quality
Sub function
Customer/Commercial Quality
Category
Analyst, Customer/Commercial Quality (P4 – E24)
Location
Santa Clara / United States of America
Date posted
Jun 13 2025
Requisition number
R-017602
Work pattern
Fully Onsite
This job posting is anticipated to close on Jun 20 2025. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
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 DESCRIPTION:

Johnson & Johnson is hiring for a Quality Compliance Specialist 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

In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Compliance Specialist will perform work under supervision. General scope of this position is to support NCR process, CAPA process, internal and external audits, data analysis and monitoring of the of key process metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

REQUIREMENTS

• Bachelor’s degree and a minimum of 2+ years of related experience in the medical device industry.
• Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus.
• Ability to compile and analyze data, present information, and demonstrate competent document writing skills.
• Excellent written and verbal communication skills.
• Basic knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems.
• The ability to understand and follow QMS Procedures. (e.g., SOP and Test Methods.)
• Experience with computer-based applications (MS Word, MS Excel, Power Point).
• Strong time management skills and the ability to multi-task in a fast-paced environment.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.

Please refer the Job description for details