Specialist Quality Assurance - Complaints
abbott · United States - Texas - Irving ·
- Category
- QA
- Experience
- 3+ years
- Company size
- 1000+
- Salary
- USD 68,000 – 136,000 / year
Reviews and investigates customer complaints for medical diagnostics products, ensuring regulatory compliance and patient safety while coordinating with internal teams and documenting findings.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
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.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
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.
What You’ll Work On
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.
Design Control / Documentation & Change Control - Identifies areas for process improvement.
Provides supporting information for change including reasons and justifications.
Quality Engineering - 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.
Required Qualifications
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.
Preferred Qualifications
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.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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The base pay for this position is
$68,000.00 – $136,000.00In specific locations, the pay range may vary from the range posted.