Postmarket Surveillance Manager, Tracking and Trending
AbbottAbout the role
JOB DESCRIPTION:
Post Market Surveillance Manager, Tracking and Trending
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
As a Postmarket Surveillance Manager, Tracking and Trending they will be responsible for the group initiating and owning investigations associated with trends and emerging issues associated with product complaints. The group also establishes processes and programs to ensure new products are capable for post-market surveillance as defined in the ADC Quality System at the time of launch. This role requires a strong technical understanding of the product, investigation methods, and the post-market surveillance space to ensure timely and effective tripped trend investigations. This role will be expected to oversee and develop a team of individuals with those same skillsets to sustain investigations and post-market surveillance capabilities as new products, methods and trends develop.
What You’ll Work On
- Hire and develop tracking and trending team.
- Establish effective team oversight of new product development to ensure post-market surveillance capabilities at time of launch as it pertains to tracking and trending ensuring.
- Responsible for establishing ADC tracking and trending methodology as pertaining to complaints.
- Work with the complaints group and PQE team to analyze product issues and determine if further action is required.
- Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross-functional evaluation, investigation, and solutions.
- Represent Tracking and Trending team at Site Management Review and Postmarket Surveillance Review meetings.
- Reviews and provides functional approval for project and quality system documentation
- Develops and implements plans, ensures milestones are met and prioritizes resource workload as required to meet commitments
- Host monthly tracking and trending meetings, ensure investigations are completed in a timely manner, prepare relevant documentation
Required Qualifications
- Bachelors Degree required, Masters Degree a plus, equivalent combination of education and work experience will be accepted.
- Minimum 6 yrs of experience as a Manager Quality Assurance required
Preferred Qualifications
- Minimum 4 years Overall quality experience in a FDA/ISO regulated environment preferred
- Substantial demonstrated initiative and problem-solving skills; critical-thinking skills, preferably in a CAPA environment
- Experience working in an investigative role in a Quality management system, in collaborations with Quality Assurance/ with Operations and R&D.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s