Senior CAPA Specialist

Abbott • Irving, TX

6d • $78,000 - $156,000 • Onsite

About The Position

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 Senior CAPA Specialist is the lead for facilitating, executing, and working to improve the CAPA process.

Requirements

• Bachelor’s degree preferably in engineering, healthcare, science fields, or an equivalent combination of education and work experience.
• Minimum 6 years significant engineering and/or technical operational experience plus demonstrated competence.

Nice To Haves

• Master’s degree preferred.
• Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
• Prior medical device experience preferred.
• Experience with assay, reagents, assay files is preferred.
• Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
• Solid communication and interpersonal skills.
• Strong technical writing 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 effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.

Responsibilities

• 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 on regular basis in accordance with established procedures.
• Support team in the delivery and oversight of 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.
• Provide support in inspection readiness activities
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Benefits

• 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.

What This Job Offers

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