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Staff Analyst Post Market Surveillance

Location
Cincinnati, OH

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Staff Analyst, Post Market Surveillance
J&J Family of Companies

Cincinnati
OH
Job #714801478
Johnson & Johnson’s Cardiovascular &
Specialty Solutions (CSS) Group within Medical Devices is recruiting for a
Staff Analyst, Post Market Surveillance located in Irvine, CA, Cincinnati, OH
or Somerville, NJ.
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.
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. Presents results, facilitates discussion
during data review meetings, proposes escalations, corrective, and preventative
actions as required. Leads projects to
improve and develop the sensitivity and specificity of surveillance processes
for medical device performance. Completes
data analysis and develops automation of the complex post market data analysis
requirements and processes using robust software such as Advanced Excel
techniques, Python and/or R. Collaborates
and interact with internal teams, including Manufacturing, R&D, Product
Quality Engineering, Customer Quality and Supplier Quality. Regularly interacts with upper management. Provides input and develops 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 softwares. 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,
executes and delivers the presentation of the post market 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.
You,
The Staff Post Market Surveillance Analyst will:
Under limited supervision, review and
continuously execute the global post market surveillance process;
Perform data analysis and automation on
the post market data set to deliver outputs per procedure and stakeholder 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 stakeholders 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 cross functional teams and
stakeholder groups on ad-hoc data analysis, data mining, data queries in
support of product performance, regulatory, compliance and other product and
safety focused deliverables/requirements;
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, Data Science, Biostatistics, Epidemiology,
Public Health, Quality Engineering, Biomedical Engineering, Computer Science,
Biology, 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 and automate data analysis (graphs, charts, pivot,
statistics etc.) using Excel or R software is required.
Experience with data analysis in 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,
Cincinnati, OH or Somerville, NJ 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
Other Locations
North America-United States-Ohio-Cincinnati, North America-United States-New Jersey-Somerville
Organization
Biosense Webster Inc. (6010)
Job Function
Quality Assurance
Requisition ID
Updated 08/11/2018

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