US Complaints & Quality Assurance Leader

Thornton Tomasetti; Columbus (OH); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott is seeking a Complaints Handling Manager for the U.S. Region, based in Columbus, OH. This role leads quality systems for laboratory and complaint handling, driving compliance and continuous improvement across the U.S. investigations and manufacturing interfaces.

The candidate will manage a team, implement QA policies, coordinate audits, respond to findings, and drive CAPA activities while partnering with cross-functional teams and external vendors.

Qualifications

• Bachelor's Degree (± 16 years).
• Food Science, Engineering, Microbiology, Biology, or Chemistry.
• Minimum 7 years.
• Food and Infant Formula industry, leading a team with little direction, quality system ownership, and laboratory.
• Experience within a manufacturing plant is a plus.

Responsibilities

• Develops quality assurance policies, strategies and regulations related to laboratory and complaint handling in the U.S.
• Assesses potential risks, ensures compliance and gives recommendations.
• Takes responsibility and manages team for all quality control aspects of the process (laboratories studies, clinical research, testing, operations, finished product or services).
• Facilitates audits, agency complaints, and regulatory inspections related to product manufactured in/shipped to the U.S.
• Respond to audit findings.
• Works with broad group of internal cross functional partners to ensure compliance, positive investigation outcomes, and timely execution.
• Meet with customers and HCPs (Healthcare Providers), as needed.
• Escalate complaints and investigation outcomes appropriately.
• Participate in on market evaluation process.
• Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards.
• Coordinates quality trainings.
• Prepare, develop, monitor, and report on monthly, quarterly, and annual metrics related to area of responsibility.
• Perform ongoing complaint monitoring and data trending related to product manufactured in/shipped to the U.S.
• Provide timely feedback on complaint inputs and investigations.
• Process, assess, and approve complaints related to product manufactured in/shipped to the U.S; prepare written responses.
• Develop and provide feedback on complaint handling standards.
• Initiate and investigate CAPAs when necessary.

Skills

Quality assurance

Regulatory compliance

Audits

CAPAs

Team leadership

Education

Bachelor's Degree

Food Science

Engineering

Microbiology

Biology

Chemistry

Job description

Abbott is seeking a Complaints Handling Manager for the U.S. Region, based in Columbus, OH. This role leads quality systems for laboratory and complaint handling, driving compliance and continuous improvement across the U.S. investigations and manufacturing interfaces.

The candidate will manage a team, implement QA policies, coordinate audits, respond to findings, and drive CAPA activities while partnering with cross-functional teams and external vendors.