Quality Assurance Manager

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: Quality Assurance Manager Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 of which you dream. 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Westfield, IN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. The Quality Assurance Manager is accountable for the Quality Operations Organization and leads a team of Quality supervisors/technicians/inspectors/specialists to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements. What You'll Work On Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources. Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews. Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals. Interacts with internal and external stakeholders, by meeting regularly, responding to requests and explaining procedures as applicable. Interprets and executes policies that affect work processes and personnel within the assigned organizational unit. Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit. Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc). Contributes to the development and monitoring of area budgets through regular analysis of cost and spending. Translates department goals into individual objectives and KPI. Identifies, develops and implements processes to improve department performance. Monitors departmental activities and records to ensure compliance. Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools. May also direct work assignments for quality control auditors. May also direct Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & engineers. May own, author, review, approve, and support CAPA activities. Supports, actively engages, and may escort internal and external auditors (BSI, FDA, KGMP, etc). Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings. Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability. Influence/Leadership: Promotes the attainment of group goals by selecting, motivating, and training capable staff Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives Planning/Organization: Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability Carries out operations within an established budget. Decision Making/Impact: Assignments are expressed in the form of tasks and objective; Generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve site commitments and program objectives established by senior management Consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity. Required Qualifications B.S. in Engineering or related field; or equivalent combination of education and work experience. 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 performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment. Technical/Business Knowledge (Job Skills): Monitors progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Cognitive Skills: Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit. Demonstrated and impactful strong project management and people leadership skills required. Ability to work in a highly matrixed and geographically diverse business environment. 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 Class II or III medical device experience or comparable regulated industry strongly preferred. Six Sigma Black Belt strongly preferred. ASQ Certified Quality Engineer strongly preferred. Industry certification preferred. Experience working in a broader enterprise/cross division business unit model preferred. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: 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 on Facebook at and on Twitter @AbbottNews and @AbbottGlobal. 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: SH Structural Heart LOCATION: United States > Westfield: 1820 Bastian Court ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time 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), Continuous walking for prolonged periods (more than 2 hours at a time 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: EEO is the Law link - Espanol: 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 it’s 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 life’s 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