Senior Specialist Quality Assurance

Abbott • Princeton, FL

2d • Onsite

About The Position

Abbott Point of Care is seeking a Senior Specialist Quality Assurance for its team at the Princeton, New Jersey headquarters. Working under broad supervision, this role manages day-to-day compliance with applicable domestic and international regulations, complaint handling activities, and Medical Device Report (MDR) submissions. The specialist ensures complaints are reviewed within established timeframes and files Medical Device Reports with the FDA, Medical Problem Reports with Health Canada, and Medical Device Incident reports with worldwide regulatory agencies, as required. The role elevates complaints requiring management or Medical Affairs guidance and drives discussions and decisions about reportability.

The position also coordinates review of medical event files, assesses potentially reportable complaints, collaborates with internal teams and international country offices, verifies vigilance reports and metrics data, and manages the Reportable Confirmed Malfunction List process. The role is based at Abbott’s Princeton, NJ headquarters and requires travel 10% of the time.

Requirements

• Associate degree.
• 2–4 years of experience in a relevant field, such as engineering and/or technical operations.
• Advanced computer skills, including statistical/data analysis and report writing.
• Strong communication, teamwork, and organizational skills.
• Ability to work in a diverse environment.

Nice To Haves

• Bachelor’s degree in engineering, healthcare, or a science field.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485:2016.
• Experience working in a broader enterprise or cross-division business unit model.

Responsibilities

• Schedule day-to-day activities to ensure timely review of medical event files within established timeframes.
• Assess potentially reportable complaints against reportability criteria and file reports as necessary in compliance with worldwide regulations.
• Work with Medical Affairs, Technical Support, Complaint Handling, and Complaint Investigation teams to obtain appropriate information and support accurate, timely reportability assessments.
• Use judgment to make timely decisions based on available facts and data, escalating issues to management when appropriate.
• Coordinate changing priorities and use tools to monitor progress and results.
• Collaborate with international country offices by providing data, answering questions, supplying information for other countries’ competent authorities, and supporting metrics and process enhancements.
• Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communication and collaboration with employees at all levels, distributors, affiliates, and authorized representatives.
• Verify vigilance reports and data compiled for metrics.
• Manage the Reportable Confirmed Malfunction List process, including running monthly reports and reporting as necessary.
• Perform other related duties and responsibilities as assigned.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree