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. 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 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 Abbotts largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you feel like youre part of a family that works together to make a difference and help nourish millions of families around the world. What Youll 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 resolution plans, verifies completion of CAPA actions. Hire and retain 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. Maintain a safe and professional work environment. Comply 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 in a related field. 8-10 years roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired. 3-5 years in a supervisory/leadership role. Demonstrated and impactful strong project management and people leadership skills required. 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. Preferred Qualifications Masters Degree. Industry certification preferred. Six Sigma Black Belt strongly preferred. ASQ Certified Quality Engineer strongly preferred. Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment. Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment. Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. 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 and a Military/Veteran friendly 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 $99,300.00 $198,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ANSC Nutrition Supply Chain LOCATION: United States > Altavista : Building 1 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter