Senior QA Compliance Specialist – Medical Devices

Abbott; Princeton (NJ); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott Point of Care in Princeton, NJ seeks a Senior Specialist Quality Assurance to manage day-to-day regulatory compliance for complaint handling and MDR submissions, ensuring timely reviews under FDA and global regulations.

You will collaborate with Medical Affairs, Technical Support, and Investigation teams to obtain needed information for accurate assessments, file reports, and drive RCML metrics while maintaining high quality standards.

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

Responsibilities

• Schedule day-to-day activities to ensure timely review of medical event files within established timeframes.
• Ensure potentially reportable complaints are assessed against criteria for reportability and reports are filed as necessary in compliance with worldwide regulations.
• Work closely with Medical Affairs, Technical Support, Complaint Handling, and Complaint Investigation teams to obtain necessary information for accurate and timely reportability assessments.
• Use good judgment to make timely decisions and know when to escalate to management.
• Coordinate changing priorities and monitor progress using available tools.
• Collaborate with international country offices to provide data and information for authorities and process improvements.
• Comply with FDA regulations and other regulatory requirements, company policies, and SOPs.
• Maintain positive communications across all levels and with distributors and affiliates.
• Perform verification of vigilance reports and data for metrics.
• Manage the RCML process by running monthly reports and reporting as needed.
• Perform other related duties as assigned.

Skills

Data analysis

Communication

Teamwork

Organizational skills

Diversity awareness

Education

Associate degree

Bachelor’s degree in engineering, healthcare or science

Job description

Abbott Point of Care in Princeton, NJ seeks a Senior Specialist Quality Assurance to manage day-to-day regulatory compliance for complaint handling and MDR submissions, ensuring timely reviews under FDA and global regulations.

You will collaborate with Medical Affairs, Technical Support, and Investigation teams to obtain needed information for accurate assessments, file reports, and drive RCML metrics while maintaining high quality standards.