Senior Quality Assurance Specialist - Abbott Park, IL OR Irving, TX

Abbott • Irving, TX

29d • $78,000 - $156,000

About The Position

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, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Senior Quality and Compliance Specialist About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and 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. Free medical coverage for employees via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of either our Abbott Park, IL or Irving, TX locations in the Transfusion Medicine business unit. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As a Senior Quality Assurance Specialist , you’ll have the chance to support site compliance activities, including both external and internal audit management. This role supports the compliance gap mitigation activities, including regulatory /standards tracking and other site compliance profile management activities.

Requirements

• Bachelors Degree or an equivalent combination of education and work experience.
• Minimum 3 years experience Quality Assurance, International Auditing, Quality Compliance Management, or related experience.
• Minimum 5 years Medical Device / Pharma
• Able to demonstrate excellent interpersonal skills, influence others on improvements and actions, and increase compliance awareness across groups

Nice To Haves

• Experience supporting audits
• Diagnostics product knowledge
• Knowledge of Quality System regulations and standards (e.g., ISO 9001, ISO 13485, IVDR)
• Experience with Power BI is a plus

Responsibilities

• Support internal and external audits to ensure successful audit outcomes, including pre-audit preparations, audit logistics during, and post-audit follow-ups
• Support Audit Readiness activities, including training staff /guidance in preparation of audits
• Support compliance gap mitigation activities through identification of risks to the division and drives cross functional resolutions to address compliance gaps.
• Generates and verifies quality system metrics at defined intervals
• Promotes awareness and understanding of quality & compliance within the division.
• Provide training to the division to increase compliance awareness
• Participate in compliance initiatives and other assigned projects

Benefits

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

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