Quality Assurance Specialist

JOB DESCRIPTION: 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. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. 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 will have access to: • Career development with an international company where you can grow the career you dream of. • 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 As the Quality Assurance Specialist, you will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, complaints, nonconformances, CAPA and/or supplier control. This role is responsible for implementing and maintaining the effectiveness of the Quality System and supporting regulatory compliance activities. What You’ll Do • Responsible for implementing and maintaining the effectiveness of the Quality System. • Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation. • Aid in implementing process improvements with respect to Quality Assurance processes. • Maintain Quality metrics as required. • Manage and/or assist with complaints, CAPA, change requests, NCMRs, deviations. • Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits). • Assist in determining quality attributes and requirements. May provide technical assistance. • Utilize quality management techniques to perform investigations and facilitate solutions. • Work with managers to coordinate training requirements for employees as required. • Manage training program and organizational chart as required. • Perform Quality System Training Requirements as needed. • Review/approve supplier surveys and make recommendations as required. • Assist with internal audits and agency audits. • Manage Document Control as required. • Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors. • Drives functional performance to ensure that cross-functional standards and expectations are met. • May assist in the training of personnel as directed by management. • Responsible for completing documentation in a timely manner and in accordance with business standards. • Manage equipment maintenance and calibration program as required. • Assist with equipment, process and facility qualification and validation activities as required. • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing ac