Senior CAPA and Complaints 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. 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 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 will work out of our Livermore, CA location in the Abbott Heart Failure, Acelis Connected Health business.  Our Heart Failure solutions are helping address some of the World’s greatest healthcare challenges.

As the Senior CAPA & Complaints Specialist, you are responsible for managing the Corrective and Preventive Action (CAPA) process and the Complaints Handling process.  In this role, you will ensure our current processes remain in compliance with regulatory requirements and internal quality standards.

What You’ll Work On

• Lead the CAPA process and Complaints Handling Process at all sites.  Represent CAPA and Complaints in CAPA Review Boards (CRB) and cross functional meetings.

• Manage the CAPA process of multiple CAPAs from initiation to closure, ensuring timely and effective resolution of issues with minimal oversight and direct others.

• Conduct thorough investigations of complex non-conformances and deviations to identify root causes and develop strategy with appropriate business acumen.

• Develop and implement corrective and preventive action plans to address identified issues.

• Monitor the effectiveness of CAPA actions and make necessary adjustments.

• Collaborate with cross-functional teams and multiple sites to ensure CAPA actions are integrated into relevant processes.

• Maintain excellent accurate and detailed documentation of CAPA and Complaint activities.

• Prepare and present CAPA reports to management and regulatory bodies as required.

• Stay updated on industry regulations and best practices related to CAPA.

• Manage the Complaint Handling Process, including updating procedures, developing new processes, and creating IT business requirement updates.

• Analyzes customer complaints, events and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary.

• Work with cross-functional teams to Investigate customer complaints.

• Leads Complaint Handling Process Improvements for all sites.

• Communicates CAPA and Complaints projects by formal presentations to management committees.

Required Qualifications

• Bachelor’s Degree or relevant education and experience.

• 5 years of related experience.

• Strong Experience with CAPA and Complaints Quality Systems

Preferred Qualifications

• 2 or more years of medical device related experience

• Knowledge of Regulated Industries

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow 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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