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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

About Abbott

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

The Opportunity

The Quality Assurance Specialist supports the US Workplace Services team within RMDx Toxicology by ensuring operational processes, documentation, and workflows comply with applicable Department of Transportation (DOT), Health and Human Services (HHS), and New York State regulatory requirements. This role ensures accuracy, data integrity, and compliance across all non-laboratory toxicology program functions, enabling high‑quality service delivery to employer testing programs nationwide.

What You'll Do

• Maintain and support the Quality Management System (QMS) aligned with DOT 49 CFR Part 40, HHS Mandatory Guidelines, and New York State Department of Health (NYSDOH) requirements.
• Draft, revise, and manage controlled quality documents including SOPs, forms, and work instructions.
• Support implementation of controlled document updates and regulatory-driven process changes.
• Perform quality control reviews for medical device complaint intake documentation to ensure accuracy, completeness, and compliance with internal standards and applicable regulations.
• Verify that complaint records are properly triaged, categorized, and documented according to established procedures.
• Ensure timely routing of complaints to appropriate stakeholders, including Legal Manufacturer.
• Support preparation of complaint-related metrics, summaries, and audit-ready documentation.
• Assist in maintaining alignment with FDA 21 CFR Part 820 (as applicable for complaint handling), company-level complaint procedures, and internal reporting requirements.
• Support internal and external audits for DOT, HHS, NY State, and customer compliance needs.
• Conduct routine quality checks of non-laboratory processes such as specimen handling, chain of custody workflows, program documentation, and reporting procedures.
• Track findings, corrective actions, and follow-up activities to maintain a continuous state of readiness.
• Investigate quality incidents, nonconformances, and customer-impacting events.
• Initiate and verify corrective and preventive actions (CAPA) for effectiveness and timely closure.
• Perform root‑cause analysis using structured problem‑solving methods.
• Review chain-of-custody forms (CCFs), custody records, processing documentation, and other toxicology program data for completeness and accuracy.
• Validate that workflows for specimen receipt, tracking, routing, and reporting meet DOT/HHS/NY requirements.
• Partner with operations teams to ensure proper execution of testing program processes.
• Maintain training and competency records for staff supporting regulated toxicology programs.
• Assist in developing training materials for compliance updates or quality system enhancements.
• Identify and support process improvement opportunities to reduce risk and enhance quality.
• Prepare reports, trend analyses, and KPIs for deviations, CAPAs, audit observations, and quality indicators.
• Present data‑driven insights to quality leadership and operational partners.

Required Qualifications

• Bachelor’s degree in Biology, Chemistry, Public Health, Quality Management, Regulatory Compliance, or related field preferred.
• 2–4 years of experience in quality assurance or compliance within a regulated environment (toxicology programs, workplace drug testing, healthcare administration, or related).
• Working knowledge of:
  • DOT 49 CFR Part 40
  • HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs
  • New York State Department of Health toxicology requirements
• Strong documentation, analytical, and organizational skills.
• Ability to work cross-functionally and communicate effectively.

Preferred Qualifications

• Experience supporting workpl