Specialist Quality Assurance - Complaints

Abbott • Irving, TX

2d • $68,000 - $136,000 • Onsite

About The Position

This position works out of our Dallas, TX location in the Core Lab, Diagnostics Division. 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 Specialist Quality Assurance will analyze customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.

Requirements

• Bachelors – Apprenticeship or Bachelor’s degree in Life Science, Engineering, or closely related discipline, or an equivalent combination of education and work experience.
• Minimum 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.

Nice To Haves

• Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement.
• Experience working within a regulated industry such as medical device, diagnostics, pharmaceutical, biotechnology, or other regulated industries) is a plus.
• Experience leading or supporting CAPA activities, investigations, root cause analysis, and quality system compliance activities.
• Knowledge of quality system requirements, risk management principles, and regulatory expectations related to investigations and/or CAPA processes.
• Excellent written and verbal communications skills.

Responsibilities

• Conduct investigations related to quality events and customer complaints in compliance with applicable regulations and internal procedures.
• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Apply clinical knowledge, as related to product application, to evaluate identified complaints.
• Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Composed written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
• Ensure investigation and records are completed accurately, thoroughly, and in accordance with regulatory and quality system requirements.
• Support audits and inspections by providing documentation and demonstrating compliance with quality system requirements.
• Utilize root cause analysis tools and problem-solving methodologies to drive continuous improvement and maintain compliance.
• Contributes to defining and timely achievement of overall project goals. Scope typically limited to one specific QA function.
• Provides compliant solutions to a variety of problems of moderate scope and complexity.
• Ensures compliance with site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.
• Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
• Identifies areas for process improvement.
• Provides supporting information for change including reasons and justifications.
• Coordinates quality decisions between different quality and engineering groups.
• Participate in the development or modification of validation packages, design plans, and risk management deliverables (e.g. FMEAs). Team members helping and interfacing with suppliers to deliver products meeting our quality requirements.
• Receives general direction and exercises considerable discretion to own work detail. Recommend possible solutions. Provides compliant solutions to a variety of complex problems.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level