Senior Specialist Quality Assurance

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.

     

JOB DESCRIPTION:

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.

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 you dream of .
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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

Our Diagnostics business currently has an opportunity for a Senior Specialist Quality Assurance for our Santa Clara, CA location. The primary function of this position is to Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes.

What You’ll Work On

• Defines project goals and milestones. Responsible for timely project completion.
• Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. May lead projects with cross-functional or broader scope.
• Interacts effectively with employees, manager, and cross-functional peers. May represent own team while on cross [1] functional project teams with other functional leaders. Communicates confidently and effectively with management, peers, and key stakeholders.
• Implements tactical solutions related to assignment. Able to contribute functional skills and expertise broadly.
• Directly influences project direction and scope. Scope includes one or more QA functions, with general knowledge of other related disciplines.
• Quality System Compliance - Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate. Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
• Risk Management - Ensures evaluation of product safety and efficacy and elevation of risk-based issues. Creates and reviews risk management documentation to reduce or eliminate risk. Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system. Authors risk control packages and demonstrates the ability to analyze, evaluate, and control risk decisions by utilizing common practices throughout the quality.
• Complaint Evaluation - Investigates complex complaints with little management oversight. Provides solutions to a wide range of problems. Solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. Ensures compliant documentation in area of responsibility.
• Design Control / Documentation & Change Control - Formulates thorough reason and justification for change. Identifies critical parameters associated with change.
• Represents the site as an SME or Process Community member.
• Quality Engineering - Applies solid understanding of qua