What are the responsibilities and job description for the Senior CAPA and Complaints Specialist position at Abbott?
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.
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
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
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.
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.
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.
- Bachelor’s Degree (± 13 years) or relevant education and experience.
- 2 or more years of medical device related experience
- Strong Experience with CAPA and Complaints Quality Systems
- Knowledge of Regulated Industries
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.
Salary : $86,700 - $173,300
