Senior CAPA Specialist

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. Youll 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 bachelors 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.

The Opportunity
This position works out of our Dallas TX location in the Core Lab Diagnostics Division. Were 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 Abbotts 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.

What Youll 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.

• 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.

Required Qualifications

• Bachelors 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.

Preferred Qualifications

• Masters 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.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

Senior IC