Quality 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 Quality Data Analyst II​ – Shockwave Medical to join our team located in Santa Clara, CA.

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 Management System (QMS) and Risk Management System

• Support MS Power BI Dashboard for Quality reports

• Assist functional teams to identify opportunities for improvement

• Assure data integrity and data validation prior to publishing reports and analysis

• Process confidential data and information according to guidelines

• Manage and design the reporting environment, including data sources, security, and metadata

• Support the data warehouse in identifying and revising reporting requirements

• Support initiatives for product performance and QMS data integrity

• Support implementation of the new/upgraded software, new products, and new country requirements

• Troubleshoot the reporting database environment and reports

• Develop dashboards for ease of data visualization

• Train end-users on new reports and dashboards

• Provide technical expertise in data storage structures, data mining, and data cleansing

• Identify and drive QMS continuous improvement activities

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

• Other duties as assigned

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Requirements:

• Bachelor’s degree in computer science, statistics, mathematics or related areas

• Minimum 2+ years’ experience directly supporting QMS data analysis, or relevant experience in medical/scientific area

• Strong background in statistics

• Skilled in SQL language and MS Power BI design.

• Knowledge of Medical Device Quality Systems (FDA QSR, ISO 13485, EU MDR etc.)

• Ability to work effectively with cross-functional teams to assess potential risks

• Ability to analyze existing tools and databases and provide software solution recommendations

• Ability to translate business requirements into non-technical terms

• High-level experience in methodologies and processes for managing large-scale databases

• Demonstrated experience in handling large data sets and relational databases.

• Excellent critical thinking skills

• Effective written, verbal and presentation skills with all levels of management and organizations

• Advanced Microsoft Excel and PowerPoint skills with the ability to manipulate data and use advanced formulas

• Operates both as a team and independently, with adaptability to changing requirements

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers  or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: