Job Details

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.

ABOUT ABBOTT

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

This position works out of our Columbus, Ohio plant 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.

The Columbus Plant is Abbott's first manufacturing facility in the world, making us a leader in science-backed nutrition products. Working here, you'll be part of a family that works together to produce quality products that make a difference and help keep consumers nourished at every stage of their lives.

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:

• Production areas that areclean, well-lit and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial securitythrough competitive compensation, incentives and retirement plans
• Health care and well-being programsincluding medical, dental, vision, wellness and occupational health programs,Medical Benefits start day 1
• Vacation– 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Retiree Healthcare program
• Robust 401(k)retirement savings with a generous company match
• Tuition reimbursement, theFreedom 2 Savestudent debt program andFreeUeducation 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 around the world and named one of the most admired companies in the world by Fortune.
• A stable companywith a record of strong financial performance and history of being actively involved in local communities
• 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 is responsible for developing, establishing and maintaining quality assurance programs, policies, processes,

procedures and controls ensuring that performance and quality of products conform to established standards and agency

regulations.

WHAT YOU'LL DO

• Management and development of Quality Systems Engineers.
• Administer and lead Corrective/Preventive Action program for all MCS sites (five different locations).
• Oversees 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.
• Provides 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.
• Maintains 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 analyses trend metrics and reports and establishes further actions, as may be required.
• Approves CAPA investigations and resolution plans, verifies completion of CAPA actions.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

REQUIRED QUALIFICATIONS

• Bachelor's degree
• 3-5 years in a supervisory/leadership role.
• 8-10 years roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality
• Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
• Demonstrated and impactful strong project management and people leadership skills.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to travel internationally to support international manufacturing sites.

PREFERRED QUALIFICATIONS

• Master's degree
• Six Sigma Black Belt strongly preferred.
• ASQ Certified Quality Engineer strongly preferred.
• Industry certification
• Experience working in a broader enterprise/cross division business unit model
• Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control&Monitoring (SPC).

Apply Now

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.Pre-Employment Inquiries and Citizenship | U.S. Equal Employment Opportunity Commission (eeoc.gov)

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

*Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

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 and a Military/Veteran friendly Employer, committed to employee diversity.

Connect with us atwww.abbott.com, on Facebook atwww.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $97,300.00– $194,700.00. In specific locations, the pay range may vary from the range posted.