Senior Specialist Quality Assurance - CAPA

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 114,000 colleagues serve people in more than 160 countries.

     

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 by Fortune.
• A company that is recognized as one of the best big companies to work for and a best place to work for diverse, working mothers, female executives, and scientists.

The Opportunity 

Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective.  Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry’s most comprehensive menu of tests in a single, with-patient platform, including blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance. 

We have an opportunity for the role of Senior Specialist Quality Assurance- CAPA within our Abbott Point of Care (APOC) team, based at our Princeton, NJ headquarters. No relocation assistance is available.

As a Senior Specialist Quality Assurance- CAPA, you'll be responsible for facilitating, executing, and working to improve the CAPA process.

WHAT YOU DO

• Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
• Participate or lead the completion of CAPA projects, ensuring compliance, quality, and timeliness of records.
• Collaborate with cross-functional teams using various methodologies (e.g., Six Sigma root cause analysis/problem-solving skills).
• Independently investigate, gather data, and perform preliminary analysis.
• Process requests, ensuring assigning to the owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
• Lead meetings and communications for CAPA updates, information, and concerns.
• Assist with metrics and reporting regularly by established procedures.
• Support the team in the delivery and oversight of the CAPA training program.
• Assist in the initiation, processing, and completion of CAPA records in the electronic system.
• Execute and provide on-time completion of Quality Assurance engineering deliverables.
• Provide support and subject matter expertise during audits and inspections.
• Lead and/or contribute to continuous improvement initiatives and projects.
• Mentor lower-level CAPA engineers.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required:

• Bachelor’s degree in engineering, healthcare, Science field, or equiv