Staff Associate, Post Market Safety Surveillance
Apply NowCompany: Johnson and Johnson
Location: Raleigh, NC 27610
Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Albany, New York, United States of America, Albany, New York, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Annapolis, Maryland, United States, Augusta, Georgia, United States, Austin, Texas, United States, Baton Rouge, Louisiana, United States, Bismarck, North Dakota, United States, Boise, Idaho, United States, Boston, Massachusetts, United States of America, Burlington, Vermont, United States, Charleston, South Carolina, United States, Charleston, West Virginia, United States, Columbia, South Carolina, United States, Columbus, Ohio, United States, Concord, New Hampshire, United States, Denver, Colorado, United States, Des Moines, Iowa, United States, Dover, Delaware, United States, Fort Pierce, Florida, United States, Harrisburg, Pennsylvania, United States, Hartford, Connecticut, United States, Helena, Montana, United States, Honolulu, Hawaii, United States {+ 27 more}
Job Description:
We are searching for the best talent for a Staff Associate, Post Market Safety Surveillance. This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.
We are looking for a highly motivated and detail-oriented Staff Associate, Post Market Safety Surveillance, to join our dynamic Safety Management Team. In this vital role, you will be at the forefront of analyzing product complaint data, identifying trends, and driving improvements. Your expertise will contribute to safer products and enhanced customer satisfaction.
You will be responsible for:
Qualifications/Requirements:
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.
Johnson and Johnson is committed to providing interview process that are inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
#LI-Remote
The anticipated base pay range for this position is :
$91,000-$147,200
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Albany, New York, United States of America, Albany, New York, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Annapolis, Maryland, United States, Augusta, Georgia, United States, Austin, Texas, United States, Baton Rouge, Louisiana, United States, Bismarck, North Dakota, United States, Boise, Idaho, United States, Boston, Massachusetts, United States of America, Burlington, Vermont, United States, Charleston, South Carolina, United States, Charleston, West Virginia, United States, Columbia, South Carolina, United States, Columbus, Ohio, United States, Concord, New Hampshire, United States, Denver, Colorado, United States, Des Moines, Iowa, United States, Dover, Delaware, United States, Fort Pierce, Florida, United States, Harrisburg, Pennsylvania, United States, Hartford, Connecticut, United States, Helena, Montana, United States, Honolulu, Hawaii, United States {+ 27 more}
Job Description:
We are searching for the best talent for a Staff Associate, Post Market Safety Surveillance. This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.
We are looking for a highly motivated and detail-oriented Staff Associate, Post Market Safety Surveillance, to join our dynamic Safety Management Team. In this vital role, you will be at the forefront of analyzing product complaint data, identifying trends, and driving improvements. Your expertise will contribute to safer products and enhanced customer satisfaction.
You will be responsible for:
- Facilitation of Complaint Trending Activities: Lead complaint trending meetings and ensure comprehensive documentation of product complaint data analysis, trend reporting, and communication of investigation outcomes.
- Cross-Functional Collaboration: Foster effective communication across the Safety Management Team to gather critical information and support escalation decisions.
- Data Analysis: Analyze monthly complaint trending data and perform in-depth analyses to identify significant trends and actionable insights.
- Utilization of Analytical Tools: Leverage Microsoft Excel, QLIK, and Tableau to create tables, graphs, and visualizations that aid in data review and interpretation.
- Preparation for Meetings: Organize and prepare meeting materials for the Safety Management Team, ensuring all necessary information is available prior to discussions.
- Investigation Management: Facilitate and manage the Investigation Decision Reports process, ensuring timely and clear communication of results through the Quality System.
- Process Maintenance: Responsible for regular updates to complaint handling process work aids, including Previous Investigation Technical Reports, Complaint Thresholds Technical Report, and Malfunctions List.
- Timely Reporting: Provide accurate and prompt product complaint data analysis and reporting, assisting in routine and ad-hoc analyses of complaint and adverse event trends.
- Tool Development: Develop and enhance existing data analysis tools while ensuring compliance with worldwide regulations.
- Metrics Reporting: Offer complaint handling metrics and reporting tools to support the active monitoring of complaint handling performance and refine query tools within the complaint database.
- Management Review Support: Create and manage Management Review slides and data for JJVC Complaint Handling and Post Market Surveillance.
- Audit Support: Support audits and inspections related to Complaint Trending, Post Market Surveillance, and Vigilance processes.
- Continuous Improvement: Actively participate in initiatives aimed at improving Global Complaint Trending, Post Market Surveillance, and Complaint Handling practices.
- Safety and Compliance: Adhere to company safety, quality policies, and procedures, ensuring compliance with QSR and MDV, MDR, MPR, and applicable regulations.
- Independent Inquiry: Work autonomously to identify areas for inquiry, understanding the importance of accuracy in decisions and recommendations regarding compliance.
- Additional Duties: Perform other related functions as assigned by management.
Qualifications/Requirements:
- Bachelor's degree required- Scientific discipline or equivalent related experience preferred (ASQ - CQA, CQE or SCQE, ISO Lead Assessor, Six Sigma Certification.)
- Minimum of 5 years' experience in technical/manufacturing field.
- Ability to interpret statistical data.
- Strong Technical writing skills.
- PC knowledge to include Microsoft office.
- Excellent interpersonal, organizational, oral, and written communication skills including ability to lead and manage cross functional meetings.
- CAPA and Non-conformance experience.
- Experience working in an FDA regulated environment.
- Experience in creating/editing work instructions/procedure through controlled documentation process.
- Basic understanding of SQL coding preferred.
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.
Johnson and Johnson is committed to providing interview process that are inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
#LI-Remote
The anticipated base pay range for this position is :
$91,000-$147,200
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year