Johnson & Johnson Careers

Post Market Surveillance Analyst

Irvine, California
Quality Assurance

Job Description

Requisition ID: 3803180219

The one CSS Group of Companies is recruiting for a Post Market Surveillance (PMS) Analyst to be located in Irvine, California.


The Cardiovascular & Specialty Solutions (CSS) Group consists of six diverse businesses aside from Neurovascular which serve a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, and Reprocessing.


You, the Post Market Surveillance Analyst will have responsibilities for any of the Cardiovascular and Specialty Solution Companies (Acclarent, Advanced Sterilization Products, Biosense Webster, Cerenovus and Mentor – Johnson and Johnson Family of Companies) which may include a span of multiple product platforms such as ENT, Infection Prevention, Electrophysiology and Surgical and Non-Surgical Aesthetics.


You, the Post Market Surveillance Analyst will collaborate with a team of statisticians, engineers and analysts in support of post market surveillance plan and report creation.


You, the Post Market Surveillance Analyst will have responsibility for:

  • Executing post market product data analysis processes.
  • Ensuring the adequacy of the documentation of post market surveillance activities in terms of regulatory compliance and technical/statistical soundness, presents results and proposes escalations, corrective, and preventative actions as required.
  • Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management.
  • Reviews and continuously executes the global post market surveillance process. Extracts monthly post market quality data and maintains compliant records.
  • Performs post-market safety and surveillance activities including data analysis, tracking/trending and signal detection.
  • Evaluates Safety Signals through data analytics mainly, Adverse Event reporting, Non-Conformance Reports, Corrective Actions/Preventative Actions, Customer Feedback and FG Product testing data utilizing the following tools/techniques:
    • Interval Frequency Analysis, Aggregate Analysis, Proportionality Analysis, and Stratification Analysis.
    • Facilitate cross-functional team meetings as well as lead and influence a variety of individuals and/or groups.
    • Executes the PMS process with a primary focus on product performance, safety and efficacy.
    • Active member of PMS data reviews for both reactive and dedicated data sources.
    • Collaborates with internal partners, mainly, R&D, Operations, Medical Affairs and Marketing.
    • Works with external partners including sales representatives. Utilizes statistical tools to provide technical groups and sales/marketing groups with the appropriate information on field product quality.
    • Develops and maintains PMS tracking and trending reports as assigned by manager. Supports Managers or Director on various projects. Works independently with minimal supervision.
  • The post market surveillance data set is large and includes reported product complaints, malfunctions, and adverse events, as well as capital equipment service records, clinical reviews, company-sponsored funded registries, post-market studies, and literature reviews. As required, responsible for summarizing trends, signals, and escalations.
  • Responsible for creating and delivering the post market surveillance plans and the post market surveillance reports for the company’s products to be used as an input into technical, safety and regulatory documentation.
  • Ensures appropriate governance of complaint coding schemes. Links post-market quality systems to risk management files as appropriate.
  • Executes filing of appropriate post-market, safety surveillance-related submissions and reports to regulatory agencies worldwide in accordance with Quality System procedures. Supports engineering and other ad-hoc data queries in support of CAPA and other post market quality related requests.
  • Completes projects/other duties as assigned. Provides support during external and internal audits of the customer quality process.

  • A minimum of a Bachelor’s degree in a technical, scientific or engineering field or a related technical field is required.
  • A minimum of 2 years of relevant experience is required.
  • An Advanced degree is preferred.
  • Ability to work efficiently with general supervision is required.
  • Strong quantitative and critical thinking skills are required.
  • Strong technical writing skills are required.
  • An understanding of basic statistical analysis is required.
  • Experience with statistical tools such as Six Sigma, Statistical Process Control, six sigma green belt or black belt certification or equivalent statistical experience etc. is preferred.
  • Experience with technical documents is preferred.
  • Demonstrated ability to identify issues in post-market surveillance, complaints and service is preferred.
  • A demonstrated analytical capability with the ability to summarize data into graphs, charts and statistics is required.
  • Experience with analysis and signal detection in a large data set is preferred.
  • Understanding of Risk Management (Medical Device) is preferred.
  • Experience working in a regulated environment or quality functional area with a demonstrated competency in quality system regulations specifically to the FDA is preferred.
  • Experience executing data management tasks is preferred.
  • Ability to write and communicate in a professional manner, including generating and presenting well-written reports and presentations is required.
  • Demonstrated ability to work effectively with cross-functional teams required.
  • Experience working with complaint investigations, root cause analysis, identification and implementation of CAPAs are preferred.
  • Ability to effectively prioritize and handle multiple activities and responsibilities is required.
  • Project management skills and the ability to maintain excellent electronic records is required.
  • Experience with basic office software tools (e.g. Microsoft Word, PowerPoint, Excel) and internet browsers (e.g. Internet Explorer, Chrome) are required.
  • Experience with electronic Complaint Management System is preferred.
  • This position is located in Irvine, CA and may require up to 10% domestic and/or international travel.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.


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
Biosense Webster Inc. (6010)
Job Function
Quality Assurance
Requisition ID