QA Specialist II

Title: QA Specialist II

Location: Plano, TX

Duration: 6 Months

100% Onsite

Summary

We are seeking a mid-level Quality Systems Analyst to support the development, implementation, and maintenance of quality management systems (QMS) in compliance with regulatory standards and support in CAPA process.

This role will focus on analyzing processes, ensuring adherence to quality policies and procedures, and coaching team members in corrective action and preventive action processes. The ideal candidate will have strong analytical skills, experience with QMS tools, and a solid understanding/experience in CAPA requirements. Field action activities

Key Responsibilities

• Maintain quality systems to ensure compliance with industry standards and regulations.
• Analyze data and processes to identify trends, risks, and opportunities for improvement.
• Collaborate with cross-functional teams to implement quality initiatives and system upgrades.
• Prepare reports and documentation for regulatory and internal stakeholders.
• Experience in Operations need NOT apply
• Medical Experience preferred

Qualifications

• Bachelor’s degree in business, science, or engineering
• 3–5 years of experience in quality or compliance roles
• Knowledge of ISO standards, FDA regulations, or similar frameworks
• Proficiency in data analysis tools (Excel, Power BI, Tableau, etc)
• Strong problem-solving and communication skills

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.