Johnson & Johnson Careers

Staff Analyst, Post Market Surveillance

Irvine, California
Quality Assurance


Job Description

Requisition ID: 1413180514

Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Staff Analyst, Post Market Surveillance located in Irvine, CA.


The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, and Reprocessing all headquartered in our talent hub in Irvine, CA.


The Staff Post Market Surveillance Analyst will collaborate and lead data analysts, statisticians and engineers in support of complaint signal detection, trending and post market quality surveillance.  Ensures the adequacy of the documentation of the post market surveillance activities in terms of regulatory compliance and technical/statistical soundness.  Present results, facilitate discussion during data review meetings, proposes escalations, corrective, and preventative actions as required.  Lead projects to improve and develop the sensitivity and specificity of surveillance processes.  Complete data analysis of the post market data using software such as Excel, Python, R, SQL etc.  Collaborate and interact with internal teams, including Manufacturing, R&D, Product Quality Engineering, Customer Quality and Supplier Quality.  Regularly interacts with upper management.  Provide input and develop new and existing post market surveillance processes. 

 

The post market surveillance data set is large and includes reported product complaints, malfunctions, and adverse patient  events, as well as capital equipment service records, clinical reviews, company-sponsored funded registries, post-market studies, and literature reviews.  The Staff Analyst is responsible for monitoring trends of specific complaint rates over time, part usage, and adverse event rates using data analysis techniques and software.  Applies, proposes and develops appropriate surveillance techniques for various portfolios of medical devices (long term implantable, re-sterilized, capital equipment, consumable products etc.)  Coordinates, leads and delivers the proposal and presentation of monthly reviews of the post market quality data.  Responsible for the documentation  and follow up activities of such meetings (i.e.: meeting minutes and action items).  Regularly communicates data analysis findings to lay audiences including members of upper management using visualization.    

 

You, The Staff Post Market Surveillance Analyst will:

 
  • Under limited supervision, review and continuously execute the global post market surveillance process. 
  • Extract monthly post market quality data and maintain compliant records.
  • Follow and develop procedures to investigate and analyze post market data to resolve significant issues
  • Lead investigations to determine the causes of those issues from a post market surveillance standpoint
  • Monitor changes in post market quality signals, propose appropriate next steps and document appropriately.
  • Determine and implement solutions to monitoring customer and product quality issues through the application of statistical software and data analysis.
  • Provide creative, thorough and practical data driven solutions to wide ranges of difficult problems.
  • 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 quality engineering, customer quality and other groups on ad-hoc data analysis, data mining, data queries in support of CAPA and other product market quality related requests.
  • Complete projects/other duties as assigned.
  • Provides support during external and internal audits of the customer quality process.  


Qualifications
  • A minimum of a Bachelor’s degree and a minimum of 6 years related business experience is required.
  • A minimum of a Bachelor of Science degree in a technical field (for example, Mathematics, Statistics, Electrical Engineer, Quality Engineering, Mechanical Engineering, Computer Engineering, Industrial Engineering, Chemical Engineering, Chemistry, Biology, Public Health etc.) or a related field is preferred.
  • Strong quantitative and critical thinking skills are required.
  • Experience working in a Quality Controlled Regulated Environment is required.
  • An understanding of statistical data analysis is required.
  • Demonstrated analytical capabilities with the ability to perform data analysis (graphs, charts, pivot, statistics etc.) using Excel or R software is required.
  • Experience performing data analysis on a large data set is required.
  • Experience with signal detection in a large data set is preferred.
  • Ability to write and communicate in a professional manner, including generating and presenting well-written reports and presentations is required.  
  • Working understanding of a statistical software language (R, Python) is preferred. 
  • Ability to work effectively with cross-functional teams is required. 
  • Ability to effectively prioritize and manage multiple activities and responsibilities is required.
  • Experience and competency with basic office software tools (e.g. Microsoft Word, PowerPoint, Excel, Outlook) and internet browsers (e.g. Internet Explorer, Chrome) are required. 
  • This position is located in Irvine, CA and may require up to 10% travel domestic and/or international travel.
 

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

 


Primary Location
United States-California-Irvine
Organization
Biosense Webster Inc. (6010)
Job Function
Quality Assurance
Requisition ID
1413180514