Principal Quality Systems Specialist - 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 Assurance

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Principal Quality Systems Specialist – 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 & other International Regulations, the Principal Quality Systems Specialist will perform work under minimal supervision. General scope of this position is to support CAPA, data analysis and continue improvements, support Quality system processes, internal and external audits, support External Standards management process and monitoring or key process metrics. This position requires frequent use and general knowledge of industry practices, techniques, regulations and standards.

 Essential Job Functions

• Assist in developing, administering, and maintaining quality system procedures and activities to ensure that the SWMI processes and products follow applicable quality standards and requirements

• Participate in external and internal inspections/audits, assist in preparing, conducting the audits and following up on the audit findings. Assist in maintaining a constant state of inspection readiness

• Identify and process preventive and corrective actions

• Compile, analyze and report QMS metrics on a routine basis

• Prepare and support Management Review Reports and KPI reporting

• Review, maintain and approve Quality System documents, records and reports including nonconformance and CAPA records, standards change requests, trending reports, and others as assigned

• Lead improvement projects to completion that may be initiated from non-conformances, audits, etc.

• Support implementation of new products and new country’s requirements within the SWMI QMS activities

• Develop and implement Standards and Regulation tracking and information collection tools, maintain Standards logs with current status, and report on progress of implementation

• Assist in mentoring and training others

• Support company goals and objectives, policies, and procedures, QSR, and FDA regulations

• Identify and drive Quality Management System continuous improvement activities

• Implementation of JnJ Standards, Procedures, Work Instructions

• Other duties as assigned

Requirements

• Bachelor’s degree and 10+ years of quality related experience in the Medical Device industry

• Excellent working knowledge of current USA Food and Drug Administration (FDA), ISO13485, MDR and other global laws, regulations and standards

• Ability to perform Internal Audits

• Strong background in administeri