Sr. Quality Compliance Specialist - Shockwave Medical

Johnson & Johnson is hiring for a Senior Quality Compliance Specialist to join our Quality 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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Shockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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 Senior Quality Compliance Specialist will perform work under general supervision. General scope of this position is to assist in maintaining quality compliance, assisting audit activities, review of lot history records, processing of non-conforming reports, maintaining data logs, assisting with External Standards management process, supporting audit activities and compiling quality metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions

• Review production and sterilization records and release of final product to inventory

  o Review production Records for accuracy and good documentation practice and compliance to respective Shockwave Medical procedures.

  o Communicate with various functions (e.g., Production, Materials, QA, QE, etc.) in a professional manner to gather additional information.

  o Compile and monitor process control data.

  o Prepare reports from data collected for trending purposes.

  • Assist with audit preparation activities, conduct and follow up of internal and external audits

    o Participate in quality system activities and support internal and external audits as requested

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

    o Communicate with Subject Matter Experts regarding the audit requests.

    • Assist with External records management process

      o Assist in managing compliance to the current revisions of the standards.

      o Coordinate standard related activities (track current revisions of the standards, follow up with standards owners on the status of implementation activities, maintenance of Standards tracker, etc.)

      o Gather information and update as needed to ensure compliance with Shockwave Medical procedures.

      • Assist with quality metrics for trending purposes

        o Collect and log data as requested.

        o Assist in preparation of presentations as needed for data analysis purposes.

        • Assist in maintaining the NCR System

          o Assist in managing overall compliance of the NCR system.

          o Work cross-functionally with other teams to track and manage NCR activities from initiation through closure.

          o Identify and implement NCR system continuous improvement activities.

          • Perform QA related data entry and generate reports as required.
          • Work cross functionally with other teams to collect information, follow up on tasks, etc.
          • Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.
          • Other duties as assigned.