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Engineering

Post Market Surveillance Senior Analyst

  • Título Post Market Surveillance Senior Analyst
  • Função Engineering
  • Sub função Quality (Eng)
  • Local Irvine, California, United States; Cincinnati, Ohio, United States
  • Postado
  • ID obrigatória 2206095606W
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Descrição

Biosense, a member of Johnson & Johnson's family of Companies, is recruiting for a Post Market Surveillance Senior Analyst.

At Biosense Webster, Inc. we have one goal — to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.

Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day. Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn.

Are you interested in making a difference in a thriving diverse company culture, that celebrates the uniqueness of our employees and is committed to inclusion? Apply today for this exciting opportunity!

The Post Market Surveillance Senior Analyst is responsible for monitoring trends of specific complaint rates over time, part usage, and adverse event rates using data analysis techniques and software packages. Applies, proposes, and develops appropriate surveillance techniques and processes for various portfolios of medical devices (long term implantable, re-sterilized, capital equipment, consumable products etc.) Coordinates, leads, develops, implements, and delivers the presentation of the quality data surveillance results on regular and frequent intervals. Responsible for the documentation and coordination of follow-up activities from data review meetings (i.e.: meeting minutes and action items). Regularly communicates data analysis findings to lay audiences including members of upper management using visualization and customized formatting.

Key Responsibilities:

  • Under limited supervision, review and continuously implement the global post market surveillance process
  • Perform data analysis and automation on the post market data set to deliver outputs per procedure and partner requirements
  • Extracts monthly post market quality data from databases and maintains compliant records
  • Follows and develop procedures and processes to investigate and analyze post market data to resolve significant issues
  • Monitor changes in post market quality signals, propose and/or lead appropriate next steps and document appropriately
  • Determine and implement data driven solutions to monitoring customer and product quality issues through the application of statistical software and data analysis
  • Provide guidance on post market surveillance processes and projects to collaborators and junior team members
  • Remain informed of new or revised regulations and/or guidelines and assesses impact on company post market surveillance processes
  • Create presentations summarizing major product quality issues and complaint trends
  • Ensure verification and validation activities of post market surveillance reports and data script outputs
  • Support multi-functional teams and partner groups on ad-hoc data analysis, data mining, data queries in support of product performance, regulatory, compliance and other product and safety focused work/requirements
  • Complete projects/other duties as assigned
  • Provides support during external and internal audits of the customer quality process.

Qualificações

Experience and Skills:

Required:

  • An understanding of statistical analysis is required.
  • Experience with data analysis in a large data set is required.
  • Proven analytical capabilities with the ability to perform and automate data analysis (graphs, charts, pivot, statistics etc.) using Excel or R software is required.
  • Strong quantitative and critical thinking skills are required.
  • Strong organizational skills, time management skills and ability to self-manage in a complex/ time critical environment is required.
  • Ability to write and communicate in a professional manner, including generating and communicating well-written reports and presentations is required.
  • Ability to work effectively with multi-functional teams is required.
  • Ability to optimally prioritize and handle multiple activities and responsibilities is required.
  • Experience and proficiency with basic office software tools (e.g. Microsoft Word, PowerPoint, Excel, Outlook) and internet browsers (e.g. Internet Explorer, Chrome) are required.

Preferred:

  • Experience with signal detection in a large data set is preferred.
  • Working understanding of a statistical software language (R, Python) is preferred.

Other:

  • May require up to 10% travel domestic and/or international travel.

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $73,000 to $102,000

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits .


At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]

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