Senior Specialist Quality Assurance

About the role

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 escalate 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

Additional information

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Pay and benefits

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.

• JOB FAMILY: Operations Quality
• DIVISION: APOC Point of Care
• LOCATION: United States > Princeton: 400 College Road East

Additional Locations

• WORK SHIFT: Standard
• TRAVEL: Yes, 10 % of the Time
• MEDICAL SURVEILLANCE: Not Applicable

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)