Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

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.

• 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 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 position of Senior Quality Assurance Specialist is within our Toxicology Business Unit. The position will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, launch process, NPI, complaints, nonconformances, CAPA and/or supplier control.

• Responsible for implementing and maintaining an effective Quality System.
• Leading and/or contributing to system, product and process improvement projects.
• Independently lead groups and projects to resolve complex issues, analyze complex problems and identify their impact, establish probabilities, draw conclusions reflecting broad business needs and ensure compliance.
• Cross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
• Contribute to the development, approval and implementation of product labeling and instructions for use as required.
• Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.
• Supporting equipment, process and facility qualification and validation activities as required.
• Supporting external agency and internal audits as needed.
• Supporting new product introduction activities.
• Assisting in product launch and SKU discontinuation activities.
• Aid in implementing process improvements with respect to Quality Assurance processes.
• Maintain Quality metrics as required.
• Provide support (management/execution) with CAPA, change requests, deviations and NCMRs.
• Work may require collaboration with other Division sites and/or other Abbott divisions.
• May manage training program.
• Manage complaints as required.
• Assist in managing supplier qualification program and support TPM management.
• Onboard suppliers per established supplier management procedures.
• Create and revise quality agreements and maintain supplier files.
• Support in supplier auditing activities.
• Perform Document Control activities as required.
• 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 activities.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Perform other duties and projects as assigned.

• BS/BA degree preferably in science or engineering or chemistry, biology, or other scientific discipline.
• Minimum of 5 years of Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics or FDA regulated industry with 3-5 years progressively responsible positions.
• Thorough knowledge and practical…