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Post Market Surveillance (PMS) Analyst
Requisition ID: 7600171219
Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Post Market Surveillance (PMS) Analyst and will be located in Cincinnati, OH.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Post Market Surveillance Analyst will have responsibilities for any of the Cardiovascular and Specialty Solution Companies (Acclarent, Advanced Sterilization Products, Biosense Webster, 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.
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.
THE POST MARKET QUALITY 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 of Science degree is required. A degree in a technical, scientific or engineering field or a related technical field is a plus. An Advanced degree is preferred.
- A minimum of 2 years of relevant experience is required. 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.
- 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 will be in Cincinnati, OH and may require up to 10% 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.
Ethicon Endo Surgery Inc (6041)