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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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 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 the best place to work for diversity, 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 tests for 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. 

Our Princeton, NJ headquarters has an opportunity for a Senior Specialist Quality Assurance - CAPA.  

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

      

What You’ll Work On

• Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
•  Participate in, or lead, the completion of CAPA projects, assuring 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 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.
• Responsible for assisting with metrics and reporting regularly by established procedures.
• Support 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.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Required Qualifications

• Bachelor's Degree in Engineering, Science, or related discipline or equivalent experience.
• Significant engineering and/or technical operational experience plus demonstrated competence. 
• Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
• Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
• Solid communication and interpersonal skills.
• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and