Quality CAPA Manager - Altavista, VA Plant

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 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

CAPA Manager

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 works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

Altavista, Va., is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you feel like you’re part of a family that works together to make a difference and help nourish millions of families around the world.

What You’ll Work On

• Management and development of Quality Systems Engineers.

• Administer and lead Corrective/Preventive Action program for all MCS sites (five different locations).

• Oversee the CAPA process from initiation to effectiveness review and ensure the CAPA process is compliant and effective and driving investigations to root cause.

• Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.

• Provide influential peer leadership with international partner site to drive proactive quality improvements.

• Identify Quality Initiatives and lead cross-functional teams to complete them.

• Provide expert level guidance and direction of the CAPA systems Body-of-Knowledge.

• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.

• Provide subject matter expertise, leadership and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues.

• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost,and proactive improvements.

• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

• Maintain the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.

• Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organ.

• Represent Quality Systems as required in support of cross-functional divisional projects. Identify Quality Initiatives and lead cross-functional teams to complete them.

• Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.

• Produce and analyze trend metrics and reports and establishes further actions, as may be required.

• Approve CAPA investigations and re