Quality Compliance Specialist II

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 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.

Essential Job Functions

• Assist with audit activities.

  • Participate in quality system activities and support internal and external audits as a Subject Matter Expert (SME) for NCR and CAPA Processes

  • Coordinate audit related activities (prepare documents, track audit requests, take notes, schedule conference room, setup communication channel etc.)

  • Interface with Subject Matter Experts regarding the audit requests

• Manage the NCR/Rework System

  • Work cross-functionally with other teams to track and manage NCR/Rework/Deviation activities from initiation through closure

  • Assist with affected product identification, segregation, investigation and final disposition

  • Conduct periodic meetings of the Material Review Board (MRB) to present NCR trends, reports and any additional data analysis as requested

  • Identify and implement QMS system continuous improvement activities to the NCR process

  • Maintain NCR procedures and records per procedure requirements

• Manage CAPA process

  • Work cross-functionally with other teams to track and manage CAPA activities from initiation through closure

  • Assist CAPA Owners with CAPA initiation, root cause investigation, CAPA actions development, tracking of CAPA actions to completion, effectiveness plan developments, review and closure of CAPA records

  • Conduct periodic meetings of the CAPA Board to present new CAPAs, status of active CAPAs, CAPA trends, reports and any additional data analysis as requested

  • Identify and implement QMS system continuous improvement activities

  • Maintain CAPA procedures and records per procedure requirements

• Compile quality metrics for trending purposes

  • Compile data and prepare presentations as needed for periodic reviews of the following Quality systems: NCRs, CAPAs, Rework, etc.

• Work cross-functionally with other teams to compile and generate periodic reports in a timely manner to support quality syst