Senior Specialist Quality Assurance

Senior Specialist Quality Assurance
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective.

We have an opportunity for the role of Senior Specialist Quality Assurance within our Abbott Point of Care (APOC) team, based at our Princeton, NJ headquarters. Working under broad supervision, manages the day-to-day compliance with applicable domestic and international regulations and activities related to complaint handling and Medical Device Report (MDR) submissions. Ensures that complaints are reviewed within established timeframes. Responsible for filing Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, and Medical Device Incident reports to worldwide regulatory agencies in compliance with regulations for the division's products. Elevates complaints requiring management and Medical Affairs guidance, drives discussions and decision-making process to determine reportability.

What You'll Work On

Responsible for scheduling day-to-day activities to ensure timely review of medical event files within established timeframes.

Ensures potentially reportable complaints are assessed against criteria for reportability and reports are filed as necessary in compliance with worldwide regulations.

Works closely with Medical Affairs, Technical Support, Complaint Handling, and Complaint Investigation teams to ensure that the appropriate information is obtained from complainants to make sure an accurate and timely assessment of reportability is made.

Utilizes good judgment and makes timely decisions considering the facts and data at hand;; knows when to elevate to management.

Coordinates changing priorities

Uses tools effectively to monitor progress and results.

Collaborates with international country offices providing data, answers to questions, information for other countries' competent authorities, metrics, and process enhancements.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Maintains positive and cooperative communications and collaboration with all levels of employees, distributors, affiliates and authorized representatives.

Performs verification of vigilance reports, as well as verification of data compiled for metrics.

Manages the Reportable Confirmed Malfunction List (RCML) process by running monthly reports and reporting as necessary.

Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

Associate degree

2-4 years of experience in the relevant field - engineering and/or technical operational

Advanced computer skills, including statistical/data analysis and report writing

Strong communication, teamwork, and organizational skills

Ability to work in a diverse environment

Preferred Qualifications

Bachelor's degree in engineering, healthcare, Science field preferred

Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485:2016

Experience working in a broader enterprise/cross-division business unit model

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.

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