Senior Specialist Quality Assurance

Abbott • Princeton, NJ

3d • $78,000 - $156,000 • Onsite

About The Position

Abbott Point of Care is seeking a Senior Specialist Quality Assurance for its Princeton, New Jersey headquarters. Under broad supervision, this role manages day-to-day compliance with applicable domestic and international regulations and activities related to complaint handling and Medical Device Report (MDR) submissions. The position 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 in compliance with regulations for the division’s products. The specialist elevates complaints requiring management or Medical Affairs guidance and drives discussions and decision-making on reportability.

The role works with Medical Affairs, Technical Support, Complaint Handling, Complaint Investigation teams, international country offices, employees, distributors, affiliates, and authorized representatives. It also performs vigilance-report and metrics-data verification, manages the Reportable Confirmed Malfunction List process, and undertakes other related duties as assigned. The position is based at Abbott’s Princeton headquarters and involves 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 medical event files are reviewed 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 complainant information and ensure accurate, timely reportability assessments.
• Use judgment to make timely decisions based on available facts and data, escalating matters 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, sharing metrics, and supporting 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, distributors, affiliates, and authorized representatives at all levels.
• Verify vigilance reports and data compiled for metrics.
• Manage the Reportable Confirmed Malfunction List process by 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 a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, described as an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

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