Johnson & Johnson Careers
Post Market Surveillance Analyst
Requisition ID: 0965180830
Sterilization Products is recruiting for a Post Market Surveillance Analyst to
be located in Irvine, CA.
Healthcare-associated infections (HAIs) have a devastating personal and economic impact, claiming the lives of 99,000 people in the U.S. each year at a cost of up to $45 billion. Ensuring that all surgical devices are properly sterilized is one-way healthcare workers can help reduce the incidences of HAIs, and Advanced Sterilization Products (ASP) has been partnering with hospitals for decades to safeguard patient health and safety. ASP has a strong track record of designing and delivering innovative infection-prevention solutions, from low-temperature steam sterilization to high-level disinfection, and is a global market leader setting the standard in sterilization.
Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products (ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans.
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.
- 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 adhoc 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 and 2 years relevant work experience is required.
- A degree in a technical, scientific or engineering field or a related technical field is a plus. An Advanced degree is preferred.
- Strong quantitative and critical thinking skills are required.
- Strong technical writing skills are 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.
- 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 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 Irvine, CA and may require up to 10% domestic and/or international travel
- 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.
Advanced Sterilization Products (ASP)