Johnson & Johnson
Quality Data Analyst II- Shockwave Medical
Johnson & Johnson, Santa Clara, California, us, 95053
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.
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. 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. 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 Support Quality Compliance and Post Market Surveillance activities by extracting and analyzing data to support quality plans/reports Support comprehensive literature searches, review of complaints, CAPAs and adverse events and clinical databases 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 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.
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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. 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. 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 Support Quality Compliance and Post Market Surveillance activities by extracting and analyzing data to support quality plans/reports Support comprehensive literature searches, review of complaints, CAPAs and adverse events and clinical databases 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 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.
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