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.
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
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/careersor contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing
The anticipated base pay range for this position is :
$75,000 - $120,750
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
