• 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 workplace drug testing programs or toxicology operations (non-lab or lab-adjacent).
• Familiarity with chain-of-custody workflows and specimen tracking requirements.
• Experience with quality event management systems, electronic QMS, or LIMS.
• ASQ certification or similar credentials in quality or regulatory compliance

What We offer

At Abbott, you can have a good job that can grow into a great career.

We offer:

• A fast-paced work environment where your safety is our priority
• Production areas that are clean, well-lit, and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives, and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and a history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal